Senior Quality Systems Specialist

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.

• Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all Quality and/or Regulatory Systems activities.
• Advise and coach Team Members on complex issues which may impact / be impacted by cGMP and/or, ISO standards. Quality or Regulatory Systems and Tools, promoting the right choices and resolution of issues that address the root cause.
• Lead initiatives with other departments, ensuring plan definition and timely execution
• Review and approve Quality and/or Regulatory Systems and Tools related documentation and training, preparing more complex documentation and tools
• Respond in audits/inspections (Internal and of Health Authorities)
• Open and maintain active and efficient communication channels along the several Hovione Sites, identifying Quality or Regulatory needs and improvements and addressing them
• Manage other Corporate Systems key activities, such as delivering on the Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.)
• Master Quality Systems’ processes and tools
• Manage complex projects/ analysis with significant impact on business
• Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
• Execute professional activities in compliance with Quality, Regulatory 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).

• University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory)
• Typically requires 5-8 years of relevant overall experience in at least 2 operational and support areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry.
• Advanced knowledge of Quality and/or Regulatory requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable with the ability to solve complex problems.
• Understanding of the business with a global insight on the company
• Knowledge of industrial safety, lean6sigma, and risk assessment applied to Quality Systems
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
• Fluency in English is a requirement
• Computer literate with good working knowledge of the MS Office package

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.