Quality Assurance Project Manager

DELPHARM Tours site is strengthening its expertise in the manufacturing of liquid injectable products by developing a new industrial offering for its customers: Pre-Filled Syringes (PFS).

Do you enjoy turning a project into industrial reality?

We are looking for a Quality Assurance Project Manager who will act as the QA reference for strategic vaccine and/or biological product manufacturing projects within an injectable aseptic environment.

Your role will be to secure the quality and GMP compliance of the project, while contributing to its industrial success, ensuring pharmaceutical requirements are met and customer requirements are fully complied with.

You will work in a GMP pharmaceutical environment, specialized in sterile and aseptic products, with complex, strategic projects involving significant business challenges.

You will be at the heart of projects aimed at evolving processes, integrating new products and contributing to the development of sterile, aseptic, biotechnological and vaccine activities.

And because tomorrow's projects are built today, you will also have the opportunity to contribute to the development of the site's expertise in biotechnology and vaccines.

Your key responsabilities :

• Lead QA project governance and quality deliverables from the design and transfer phases through qualification, validation, production start-up and project closure.
• Identify and manage GMP risks and challenge technical decisions.
• Support industrial transfers / Transfer-In activities and technical discussions with customers.
• Ensure QA requirements are fully integrated into qualification and validation activities, including equipment, processes, cleaning, aseptic processes / APS and packaging.
• Challenge and oversee deviations, investigations, CAPAs and Change Controls.
• Review and approve the project's GMP documentation.
• Participate in customer audits and regulatory inspections.
• Coordinate the various QA areas of expertise and drive actions forward without direct hierarchical authority.
• Lead project teams and Steering Committees (COPIL).
• Ensure project reporting and lessons learned / feedback.

Above all, we are looking for a professional who can influence and engage teams to turn Quality issues into concrete solutions.

Your profile :

• Engineer, Pharmacist, Process Engineering, Biotechnology, Microbiology or equivalent scientific/technical background.
• At least 15 years of experience in the pharmaceutical industry, including experience in leading cross-functional Quality projects related to the manufacturing of vaccines and biological products, with strong knowledge of GMP Annex 1 & 2.
• Experience working in Fill & Finish sterile / aseptic and injectable environments, process validation will be particularly valued.
• Professional French is essential for interactions with internal contacts.

You will work at the crossroads of the various Quality Assurance processes — Operational QA, Quality Systems, Qualification/Validation, Sterility Assurance, Supplier Quality, Compliance — and will be able to defend a Quality position whenever GMP risks require it.

Do you enjoy understanding, challenging, engaging teams… and, above all, making projects happen?

Join us and “Let’s develop our future together”.