Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Ensure that all applicable Quality guidelines and regulations are followed, as appropriate for each product development phase or commercial stage
- Manage and coordinate own area objectives and Key Performance Indicators, measuring the results and assuring its accomplishment
- Oversee all QA organization in the Site under his/her responsibility to assure that all applicable procedures, established objectives and approved financial budgets are followed and achieved
- Be the liaison to all key decisions, plans and rules established by the Corporate Management and ensure implementation as adequate
- Make decisions on global quality matters with the Quality Director peers and to direct the team in regard to what is the best option whenever there are conflicts of interests
- Authorize Regulatory inspections at site upon request by Competent Authorities
- Participate in client’s audits when required
- Execute internal audits and audits to suppliers with other Hovione members according to the established plans, needs and the criticality of the audits
- Create an environment where continuous improvement is part of the teams’ activities and drive for the simplification of procedures and daily tasks
- Manage the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity
- Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.
- Locally source and procure for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimized categories spend.
- Develop, with the support of more senior professionals, the appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities.
- Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values in order to establish long term relationships with suppliers who share values to enable the company to outperform competition.
- Provide the local organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies.
- With the relevant support, develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation.
- Establish relationships with the local key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives.
- Negotiate purchasing terms and conditions to ensure optimized financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives.
- Apply and develop knowledge of procurement and participate in area processes, procedures and projects with the guidance of more senior colleagues.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including external customers, suppliers, sponsors and team members.
- Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers.
- Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned.
- Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or company best practices.
- Lead the project team to take decisions and influence key stakeholders with integrity.
- Participate in project team composition and selection.
- Clarify project team roles and responsibilities and enable others to optimize their use of technical, management and leadership skills.
- Communicate proactively and effectively internally and externally, building rapport with key stakeholders.
- Give timely and specific feedback to the project TMs regularly, both positive and constructive.
- Develop knowledge related to PM methodologies, tools and techniques.
- Manage complex projects/ analysis with significant impact on business.
- Make quality and timely decisions based on multiple sources of data.
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
- Follow all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
This person will manage all instrument and electrical maintenance activities at our Loures site, both preventive and corrective. Will also manage our instrument calibration workflow.
- Contribute to the implementation of strategies on the design, acquisition and maintenance of facilities and equipment to guarantee the maximum reliability of the company assets.
- Provide technical solutions for unexpected events during the life cycle of installations and return such learnings to the ones in charge for engineering standards.
- Advise in the selection outsourced engineering, maintenance or facility contracts and resources to meet site requirements.
- Ensure that continuous improvement and lean thinking is used in all departmental activities
- Select the best performers for career advancement in accordance with the organization needs.
- Manage and support the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies
- Establish the annual objectives for all of his/her direct reports and follow up accordingly.
- Ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Guarantee that facilities respect Regulatory, National laws and Health authority requirements.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure compliance with GMP internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
- Responsibility for the identification, development, submission and management of R&D Grants/subsidies in support of the Hovione innovation strategy
- Oversees all R&D grants at Hovione globally in cooperation with areas and supports technical areas as required. Promotes the scientific excellence and innovation at Hovione.
- Ensure continuous environmental monitoring for grant and external funding opportunities at local, national, and international (EU, North America, etc) levels
- Is able to rapidly understand diverse technical fields and topics and work closely with multiple subject matter experts and external organisations to assemble grant applications with a high probability of success.
- Contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Supervise all projects within his/her portfolio, ensures that execution is flawless and that adequate resources are allocated to meet the project goals and all deliverables are met in time
- Ensure the information flow between the Hovione and grant providers/partners,
- Promote scientific excellence and innovation within the team and support in the implementation of new technologies/methodologies
- Develop and propose for management approval the strategy for grants and external funding across Hovione activities plan and related budget for the Areas in line with the company strategy, in order to align activities with strategic objectives
- Monitor budget and identify any deviations between the real and the foreseen to take corrective measures
- Ensure compliance with grant guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.
- Source and procure for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimized categories spend.
- Develop, with the support of more senior professionals, the appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities.
- Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values in order to establish long term relationships with suppliers who share values to enable the company to outperform competition.
- Provide the local organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies.
- With the relevant support, develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation.
- Establish relationships with the local key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives.
- Negotiate purchasing terms and conditions to ensure optimized financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives.
- Apply and develop knowledge of procurement and participate in area processes, procedures and projects with the guidance of more senior colleagues.
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities;
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
- Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, and other GMP related documentation for all processes run in operations;
- Participate and ensure, with supervision, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities;
- Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time;
- Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns;
- Act as a delegate of the lead process engineer and takes an active role liaising with Hovione and customer project teams;
- Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs;
- Provide training on manufacturing processes to operational team members ensuring they are appropriately trained to perform the process related tasks;
- Follow all annual performance review requirements, including completion of the self-assessment.
Increases sales team effectiveness by providing appropriate tools, processes and support. These include managing the bidding process and the RFI process, managing the CRM system and the demand review process, providing sales analytics and reporting, supporting the sales forecasting process, providing training about Hovione offerings, and supporting with business operations activities.
- Participate in the creation of the department strategy and planning, co-creating the strategy and procedures for assessment & 3P area in alignment with business goals.
- Guarantee that the assessments are conducted in a timely and efficient way, maximizing the profitability.
- Oversee the activities of the TM’s, giving direction in complex projects.
- Coordinate multi-site economic evaluations and 3P of products under VUCA, leading others in the elaboration of business proposals, project budgeting and variance analysis.
- Develop and/or approve the economic evaluations processes of the area, including defining and monitoring the SLA’s.
- Guarantee the necessary inputs for complex economic evaluations from internal stakeholders at all sites, leading interactions with key people internally.
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with sales enablement department strategic objectives.
- Monitor the Assessment & 3P´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Lead the technical aspects of multiple complex projects
- Assess different options and recommends an approach to deliver on the agreed work plan
- Provide troubleshooting support to less experienced Team Members
- Generate technical documentation related to own projects and review others
- Provide technical assessment of new projects as well as technical support to other areas
- Actively propose improvements of processes and procedures
- Generate Intellectual Property and promote scientific activities & innovation
- Develop/propose new methodologies/technologies to increase R&D efficiency
- Contribute to Hovione branding by actively participating in Scientific Events, speaking at conferences, etc
- Act as lead in inspections and internal and external audits related to R&D projects
- Represent Hovione with clients during technical and business assessments
- Network with senior internal/external personnel outside own area of expertise
- Act as a resource and mentor to TMs in own areas of technical expertise
- Train others in subjects related to own area specifics/expertise
- Master scientific investigation processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
- Perform and lead the Group Members to perform project management according to the principles defined by industry standard methodologies such as PMI PMPMBOKMBOK and in compliance with internal processes and requirements.
- Promote the continuous development of the Project Management Group Members so that they can set and maintain standards of excellence in Hovione project execution and management for all Customers as well as internal stakeholders.
- Assure the motivation of the Group Members by encouraging and offering them challenges that lead to an increase of knowledge within the area of Project Management as well as implementation of best practices, standardized approaches and process simplification related with Project execution and management at Hovione.
- Contribute for efficiency improvements in other areas that impact directly with the Project Management Group functions.
- Ensure proactive and transparent communication internally and with the Customer.
- Support definition of invoice schedule CRM CRM and request invoices (RD)CRM CRM according to the Payment schedule defined in the contracts with Customers.
- Coordinate TMs TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure TMs TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with the area's strategic objectives.
- Monitor the area’s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure compliance with internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs.
- Comply with all applicaGMP GMP HSE HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedurCOPsCOPs, HBR, SOPs and others) within his/ TMs TMs.
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- Ensure Talent Management strategies that align with our business goals;
- Guarantee that organization-wide Talent Management and initiatives are focused and aligned on improving operational and program efficiencies and effectiveness;
- Provide expertise and support in the design, development, and implementation of the talent review process;
- Lead the annual talent identification process, partnering with senior leaders to create and implement development plans;
- Develop, initiate and maintain effective programs for workforce retention, promotion and succession planning;
- Manage the performance management system; plan and implement the company's annual performance management process;
- Support and lead holistic organizational design diagnostics, identifying thematic operating improvement themes to support business case drafting and internal investment process;
- Use organizational design methodologies and principles to form future-state people & location strategies that deliver on business and functional objectives;
- Manage cross functional projects.
- Direct the development, growth and ongoing profitability of the site, by ensuring that the site is properly staffed to meet customer demand with the appropriate capabilities to support the business strategies and P&L objectives.
- Together with the VP of Technical Operations, Sales and other Hovione functional leaders develop the annual revenue plan and working budget for the site.
- Together with the VP of Technical Operations establish the priorities for future investments in the site.
- Develop and implement an effective communication strategy to present the technologies and services of the site to customers and build effective liaison/relationships at appropriate levels with customers.
- Develop and implement a review and reporting process for the site to evaluate progress against business and budget objectives, and to discuss and decide future priorities and resources.
- Ensure future growth of the site through an active involvement with Business Development in developing a R&D pipeline and executing on growth projects.
- Drive a culture of continuous improvement through the effective use of Operational Excellence tools and approaches.
- Ensure site compliance with GMP standards, with customers and external government agencies and other regulatory requirements.
- Ensure compliance with Health, Safety and Environmental policies and regulations.
- Develop for approval and deliver the short, mid, and long-term site objectives and KPIs, annual budget and budget plan, in alignment with Hovione strategic objectives.
- Manage the team members assigned to the area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, to ensure all team members are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Ensure compliance with GMP guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- Define and implement the organizational structure of the NJ site, anticipating or adapting to changing environment.
- Represent the Company to external parties.
Guiding end-to-end process improvement, installing operational efficiency, and fostering positive behaviors.
Exhibiting adept leadership by aligning priorities across diverse areas.
Implementing optimal methodologies to enhance workforce efficiency while establishing metrics for plant and equipment capacity, contributing to improved layouts, and adherence to established guidelines.
- Solid familiarity with the principles and practices of the Daily Management System is essential;
- Ability to lead teams in the effective adoption and integration of the system;
- Capability to evaluate daily data, identify patterns, and implement continuous improvements;
- Excellent communication skills to train teams and articulate the benefits of the system;
- Ability to customize and adapt the Daily Management System to meet the specific needs of the organization;
- Results-oriented, aiming for measurable improvements in daily performance.
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Define, propose for approval and guarantee the implementation of strategies for the area under responsibility (Health, Safety or Environment), as well as action plans.
- Set targets for the area of expertise, developing plans to meet those targets and overseeing their delivery.
- Monitor the effective implementation of appropriate HSE procedures in the area of expertise, guaranteeing its updating in line with changes in legislation, regulation and company directives.
- Coordinate internal and external audits in the HSE area of responsibility.
- Propose the implementation of new measures and procedures related with the HSE area of expertise to ensure the mitigation of risks.
- Take part in accident / incident investigating, guaranteeing the identification of a root cause and the elaboration of mitigation plans
- Coordinate the elaboration of management reports, briefings and KPI analysis as requested in the area of expertise.
- Coordinate in-house training on the assigned area of expertise.
- Coordinate risk assessment in the area of expertise.
- Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
- Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with the department strategic objectives.
- Monitor own´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
- Assure cGMP compliance before, during and after validation/qualification activities of systems/equipment and manufacturing processes by assuring that all necessary procedures are implemented and are being followed
- Assure that systems/processes/methods are qualified/validated according to their intended use and product requirements
- Promote the importance of high-quality levels and the importance of a continuous improvement culture in core company activities
- Support Quality and Operational areas, promoting a continuous improvement culture and compliant with the applicable regulations and approved procedures
- Participate in the alignment and harmonization of the Qualification and Validation procedures within all Hovione sites, as requested by Corporate function
- Contribute for the alignment of Qualification and Validation methodologies among Digital (Automation/IT), Engineering, Maintenance, Production Areas and Quality Control, when applicable, to benefit systems compliance
- Participate in Conceptual, Basic and Detailed Design Review for Projects of each Hovione Site, and major Projects at any Site for Corporate function, in order to assure GMP compliance with applicable Guidelines, Corporate Procedures and any specific Site requirements
- Provide input to Plan and/or establish Qualification and Validation requirements for each project within the Team
- Establishes the required qualification activities of new or changed systems and/or facilities within the change control process
- Prepare VMPs for Projects of each Site, collaborate in the VMP for major Projects and support Project’s execution at each site, for Corporate functions
- Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems’ related documentation such as Periodic
- Review Reports, at Site level Participate in the management of Quality Systems key activities
- Prepare/review Quality Systems methodologies related to the area objectives and provide training for the sites
- Propose qualification/validation related procedures and documents to be followed
- Participates or support internal or external/customer audits and health authority inspections
- Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility
- Propose improvements to the area as appropriate and solve problems
- Make quality, safely and timely decisions within the Qualification and Validation tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Propose and implement complex and thorough HSE policies, procedures and guidelines in the areas of expertise as requested.
- Create incident reports and perform inspections to ensure conformity in the HSE areas of expertise.
- Lead internal audits in the HSE areas of expertise.
- Lead audits conducted by external parties.
- Propose and implement complex HSE systems and standards to facilitate the capturing and analysis of HSE statistics.
- Conduct complex risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects.
- Lead the investigation of incidents/accidents as required.
- Lead regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines.
- Coordinate key HSE projects with operating and other technical units, guaranteeing the execution of the project.
- Contribute to the HSE training strategy and propose training goals and contents.
- Coach senior members of the company in HSE practices and principles.
- Delivery internal training sessions in the HSE areas of expertise to key people in the organization.
- Keep abreast of new legislation and regulations in HSE in the regions and area of expertise under responsibility.
- Demonstrate track record in HSE.
- Solve complex problems with full autonomy.
- Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects.
- Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals.
- Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization.
- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
- Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives;
- Prepare, revise and approve technical documentation of Engineering Projects, for conceptual, basic and detailed design phases;
- Ensure that project documents are complete and optimal for a competitive tender process;
- Prepare the project budget & timeline, and control them during execution;
- Supervise the construction, installation, commissioning and qualification of assigned projects, within is area of responsibility;
- Support the internal and external Engineering teams, integrating the work with other specialties into the final project solution, assuring user deadlines are met and without unexpected delays in production;
- Work with the other Engineering areas and project management to resolve project issues, ensuring the delivery/completion of the project work;
- Capture user feedback and lessons learned for future projects;
- Propose improvements (procedures, organizational, new technologies, capex, productivity) in Engineering as appropriate;
- Make quality and timely decisions within the Design Engineering tasks under his/her responsibility;
- Create and select the technical documentation to be used as a learning tool for new engineers, a reference for future projects and a historical repertoire (e.g., for assessments and investigations).
- Design, project coordinarion and execution/qualification of strategic projects across all sites as part of the Global Engineering team;
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Performs automation and qualification activities on facilities, equipment and utility systems, according to regulatory demands (cGMP, GAMP, FDA requirements, etc), industry applicable guidelines and internal procedures;
- Planning, executing and supervising new or business continuity projects (MS Project, Meeting project deadlines and operation targets, milestones);
- Prepare Project Budgets and Coordinate outside contractors working on facility projects;
- Proactively develop, maintain, drive and communicate project timelines to broader cross-functional team on a weekly basis.
Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
- Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including:
- a low to medium cumulative sales / project cost value
- a low to medium to high project control level
- up to a medium customer segmentation level
- Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned
- Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices
- Lead the project team to take decisions or to decide to escalate the decision based on data
- Contribute to the project team composition and selection
- Clarify project team roles and responsibilities
- Communicate proactively and effectively internally and externally
- Build and sustain motivation of the project TMs and positive dynamics within the project team
- Give timely and specific feedback to the project TMs regularly, both positive and constructive
- Keep up to date on the best PM practices, standards and methodology in use within the industry
- Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Propose improvements to the area as appropriate and solve problems
- Make quality and timely decisions within the project management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Enable and coach the Project Managers to lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
Main responsibilities:
- Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the Senior Director PMO.
- Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner.
- Oversee the integration of program and project processes
- Develop organizational governance frameworks, hierarchies, and relationships
- Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators.
- Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy
- Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction
- Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations
- Assign program and project managers to programs and projects
- Manage the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity
- Develop and propose for approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual area budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures.
- Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT
- Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
