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Key Responsibilities:
- Manage medium - to high - complexity pharmaceutical projects, ensuring alignment with business priorities
- Take full ownership of project scope, budget, timelines, and quality across all assigned initiatives.
- Lead cross-functional project teams, fostering accountability, decision-making, and stakeholder engagement.
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- Develop and execute commissioning, qualification, and validation protocols (DQ, IQ, OQ) for automation and control systems;
- Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 during all phases of system implementation and operation;
- Author and maintain validation documentation, including protocols, reports, and traceability matrices for computerized systems;
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- Develop, configure, and implement software for PLC, DCS, and SCADA systems across various automation platforms;
- Translate functional design specifications into reliable and maintainable automation code;
- Troubleshoot and resolve software issues during project execution and post-implementation support phases;
- Build and maintain strong, long-term relationships with senior decision-makers and key influencers within a designated portfolio of customer accounts, which may include major strategic clients in specific geographic or industry sectors
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Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Ensure the effective and proactive flow of information and requests between the QC team...
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.
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.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- To organize and define daily priorities within their assigned tasks in order to accurately...
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.
Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers and influencers at an assigned group of customer accounts that may include major strategic customers within a geographic or industry focus. Identifies, develops and closes new sales opportunities. Creates demand for the organization’s products, solutions and services by raising their profile with customers. Achieves revenue targets by increasing revenue spend per account. Negotiates, with autonomy, highly complex and long-term contracts. May conduct regular status and strategy meetings with the customers’ senior management to understand their needs and link them to the...
Promotes and sells a portfolio of products and/or services and solutions directly to current and new end customers. Informs customers of new product/service introduction and prices. Creates, monitors and revises lead generation plans to ensure a substantive sales opportunity pipeline. Negotiates, with autonomy, highly complex contracts.
- Achieve and deliver personal sales targets, maximizing profitability of new business.
- Prospect for new customers and projects through professional...
Hovione is a global CDMO dedicated to helping pharmaceutical clients bring innovative therapies to market. We are now hiring a Senior Quality Manager to join our Lisbon-based team. This role is a strategic leadership position with oversight of quality systems, compliance, and regulatory readiness for our manufacturing operations, with a focus on API, raw materials, and drug product environments.
We are seeking an experienced professional from the
- Provide scientific leadership and act as a subject matter expert in analytical development to support R&D process development and other relevant areas.
- Collaborate effectively with internal and external stakeholders to optimize experimental design, troubleshoot technical challenges, perform sample analysis, interpret data, generate reports, and communicate results promptly to key project stakeholders.
- Recommend and oversee the analytical characterization package (chemical, physical, performance) while ensuring the quality and...