Site Quality & Regulatory Leader – Paris

Charles River Laboratories; Paris; Sur place; EUR 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Bonus incentives

401K

Paid time off

Stock purchase program

Health coverage

Wellbeing support

Résumé du poste

Charles River Laboratories seeks a PathQuest Paris Site Head of Quality to lead day-to-day QA and regulatory operations, ensuring QMS compliance with EU GMP and global standards, while overseeing site quality personnel. Responsible for CAPA, deviations, audits, and regulatory filings with health authorities, reporting to the Global Head of Quality & Regulatory Affairs, BTS.

The Associate Director will hold the Pharmacien Responsable/QP mandate, engage with health authorities and clients, and

Qualifications

• Advanced scientific degree; European pharmacy diploma preferred.
• 5+ years of QA/regulatory experience in pharma/biotech.
• 3+ years in site quality leadership or managerial role.
• CNOP registration eligibility required.
• Strong knowledge of EU GMP, FDA, EMA, ICH.
• ATMP/MTI experience preferred.
• Experience with SMF/BMF/BLA/DMF/IND/IMPD dossiers.

Responsabilités

• Lead PathQuest Paris site quality organization and manage QA personnel.
• Define regulatory strategy and manage dossier submissions with health authorities.
• Interface with clients and health authorities; provide hands-on quality leadership.

Connaissances

Quality assurance

Regulatory affairs

Leadership

EU GMP compliance

Formation

Master’s or PhD in a relevant discipline

European pharmacy diploma or recognized equivalent

Description du poste

Charles River Laboratories seeks a PathQuest Paris Site Head of Quality to lead day-to-day QA and regulatory operations, ensuring QMS compliance with EU GMP and global standards, while overseeing site quality personnel. Responsible for CAPA, deviations, audits, and regulatory filings with health authorities, reporting to the Global Head of Quality & Regulatory Affairs, BTS.

The Associate Director will hold the Pharmacien Responsable/QP mandate, engage with health authorities and clients, and