Site Quality Director – Pharma Ops (CDMO)

Beautiful Recruitment; Louvres; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Our Client seeks a Pharmaceutical Activities Site Director to establish and lead a brand-new pharma logistics site in Louvres, France. The role focuses on building QA operations from scratch with high autonomy, including future batch release as onboarding progresses.

The candidate will oversee quality, regulatory affairs, and QMS implementation, ensuring GMP/GLP compliance and successful interactions with ANSM and other authorities. Fluency in French and English is required.

Qualifications

• Minimum 5 years in pharmaceutical manufacturing.
• At least 5 years in QA and regulatory compliance in pharma.
• Must have CNOP Section B and be French IQP/QP.
• Must have 5+ years in site leadership roles in pharma.
• Experience with vaccines/ATMP/sterile injectables.
• Fluent in English and French (written and spoken).
• Strong GMP/GLP knowledge; ISO 9001 knowledge is a plus.

Responsabilités

• Lead QA operations and maintain the QMS across the site.
• Oversee batch release activities and regulatory compliance.
• Organise, support and manage pharmaceutical activities department.
• Ensure regulatory compliance and lead health authority inspections.
• Manage CAPA, deviations, change control and internal audits.
• Draft and approve procedures; coordinate staff qualifications.
• Prepare regulatory dossiers and support site projects using Veeva/eQMS.
• Lead audits of suppliers, subcontractors and client sites.

Connaissances

QA leadership

Regulatory compliance

QP certification

CNOP Section B

Site leadership

GMP/GLP knowledge

ATMP/biopharma experience

English/French fluency

Formation

CNOP Section B, French CNOP

QP certification

Description du poste

Our Client seeks a Pharmaceutical Activities Site Director to establish and lead a brand-new pharma logistics site in Louvres, France. The role focuses on building QA operations from scratch with high autonomy, including future batch release as onboarding progresses.

The candidate will oversee quality, regulatory affairs, and QMS implementation, ensuring GMP/GLP compliance and successful interactions with ANSM and other authorities. Fluency in French and English is required.