QA Director: Greenfield EU GMP Biotech Facility

Phagos; Suresnes; Sur place; EUR 150 000 - 190 000; Plein temps

Résumé du poste

Phagos seeks a Head of Quality Assurance to design, implement, and lead the QA function for our new GMP facility. Initially based at our head office in Suresnes, with a full transition to the Evry site as operations commence, you will build the QMS from scratch and lead regulatory activities with ANMV and EMA.

You will oversee validation, batch release, deviations, CAPA, and inspections, while building a strong QA team and fostering a proactive quality culture across R&D, production, and

Qualifications

• Master’s degree or PharmD in a life sciences field with GMP/QA exposure.
• QP qualification is advantageous for site authorization oversight.
• 8–10 years of biotech/pharma QA experience on GMP manufacturing sites.
• Experience building greenfield site authorization and EU regulatory interactions.

Responsabilités

• Design, implement, and build the site QA function and QMS from scratch.
• Lead ANMV Autorisation d’Ouverture and EMA MAA regulatory activities.
• Oversee validation, batch release, deviation management, CAPA, and inspections.
• Build and lead a QA team, promoting a proactive quality culture across functions.

Connaissances

Quality Assurance

Regulatory Submissions

Leadership

GMP

Documentation & QMS

Formation

Master’s degree or PharmD in Pharmacy, Pharmaceutical Sciences, Biotechnology, or related Life Sciences

QP qualification under Article 97 of Regulation (EU) 2019/6 (advantage)

Description du poste

Phagos seeks a Head of Quality Assurance to design, implement, and lead the QA function for our new GMP facility. Initially based at our head office in Suresnes, with a full transition to the Evry site as operations commence, you will build the QMS from scratch and lead regulatory activities with ANMV and EMA.

You will oversee validation, batch release, deviations, CAPA, and inspections, while building a strong QA team and fostering a proactive quality culture across R&D, production, and