Site Quality Head & Qualified Person M/F

We are partnering with a specialized biologics testing and viral safety CRO, part of a top-tier global life sciences organization. Known for its cutting-edge proprietary NGS (Next Generation Sequencing) platforms, the company provides expert end-to-end quality control solutions for innovative biotech companies worldwide.

What You\'ll Do

Site Quality Leadership

• Lead, manage, and develop the site quality organization with full people management accountability.
• Own and continuously improve the site QMS in compliance with EU GMP, 21 CFR Part 11, ANSM requirements, and global standards.
• Lead site readiness for regulatory inspections and client audits, acting as the primary site quality representative.

Pharmacien Responsable / Qualified Person (QP)

• Fulfill all legal and regulatory obligations of the Pharmacien Responsable as defined under Article R of the French Code de la Santé Publique.
• Serve as the site\'s Qualified Person (QP) for GMP activities; certify batches in accordance with applicable regulations and marketing authorizations.
• Hold and maintain the site\'s MOT authorization.
• Serve as the primary point of contact with ANSM and other competent health authorities.
• Designate and oversee the interim QP to ensure continuous QP coverage.

Regulatory Affairs

• Define and implement the site\'s regulatory strategy in alignment with R&D objectives.
• Manage lifecycle maintenance of regulatory dossiers (BLA, DMF, SMF, BMF, IND, IMPD).
• Respond to regulatory authority requests and maintain active legislative monitoring.

Profile

• Mandatory Prerequisite: European pharmacy diploma (or recognized equivalent) and eligibility for registration in Section B of the Ordre des Pharmaciens (CNOP).
• Experience: 5+ years in QA/RA within pharma/biotech, with at least 3 years in a site quality leadership capacity.
• PR Experience: Minimum 5 years as a Delegated or Deputy Pharmacist; minimum 6 months as a Quality Control Manager (or equivalent).
• Technical Skills: Deep expertise in EU GMP, ANSM regulations, and international frameworks (FDA, EMA, ICH). Experience in biologics, viral safety, cell/gene therapy, or a CRO/CDMO environment is strongly preferred.
• Languages: Fluent in both English and French (written and verbal).
• Leadership: Proven people management skills with the ability to communicate effectively with regulatory authorities, clients, and global senior leadership.