Responsible Pharmacist & QA Manager

Title: Responsible Pharmacist & QA Manager

Location: Bourdeaux, France

About the Company:

An established international clinical supply business supporting pharmaceutical and biotech companies across clinical and commercial development. Its French operations specialize in clinical trial packaging, labelling, QP release, storage and distribution.

The role:

You will lead site Quality and take responsibility for the site's pharmaceutical operations.

• Ensure compliance with French pharmaceutical legislation, GMP and GDP.
• Oversee packaging, importation, storage and distribution activities.
• Maintain and improve the Pharmaceutical Quality System.
• Lead QA, QC, validation, qualification and metrology.
• Oversee batch certification, recalls, deviations, CAPAs and change control.
• Manage regulatory inspections, client audits and ANSM relationships.
• Lead and develop a multidisciplinary team of approximately 15.
• Drive quality strategy, operational performance and continuous improvement.

About You:

• Doctor of Pharmacy, eligible for registration as a Pharmacien Responsable in France (Is a must).
• Strong pharmaceutical Quality and/or Regulatory Affairs experience.
• Excellent knowledge of GMP/GDP and European pharmaceutical regulations.
• Experience with inspections, audits and health authorities.
• Proven leadership of multidisciplinary teams.
• Fluent in written and spoken English.

Reach out to me on [email protected] or via LinkedIn with any questions!