QA Manager

PQE Group; Marseille; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global leader in the Pharmaceutical industry is seeking a highly experienced QA Manager located in France. The ideal candidate will have over 15 years of QA experience, proven expertise in managing Change Controls, Deviations, and CAPAs, and strong knowledge of GMP regulations. Fluency in both English and French is required. This position offers the opportunity to work on international projects in a collaborative and dynamic environment.

Prestations

International projects

Career development opportunities

Qualifications

• 15+ years of QA experience in the pharmaceutical sector.
• Proven expertise in Change Control, Deviation, and CAPA management.
• In-depth GMP knowledge with strong Annex 11 expertise.
• Experience in quality system remediation and audit readiness.
• Leadership track record as Team Lead, QA Manager, or Principal Consultant.
• Fluency in English and French (written and spoken).

Responsabilités

• Review, prioritize, and close 700+ open Change Controls.
• Investigate and resolve 107+ open Deviations.
• Manage and close 187+ open CAPAs.
• Conduct root cause analysis using tools like 5 Whys and Fishbone.
• Ensure compliance with GMP and data integrity requirements.
• Provide training to internal teams to prevent issue recurrence.

Connaissances

Change Control management

Deviation management

CAPA management

Root cause analysis

Process improvement

GMP knowledge

Fluency in English

Fluency in French

Outils

TrackWise

Veeva

MasterControl

Description du poste

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Job Overview

Due to our continuous growth, we are currently seeking a highly experienced QA Manager to support our client in resolving a significant backlog within their Quality Systems, including Change Controls, Deviations, and CAPAs. The ideal candidate will have a proven track record in quality system remediation, root cause analysis (RCA), and process improvement within a GMP-regulated environment.

Location : Paris, France.

Responsibilities

• Review, prioritize, and close 700+ open Change Controls, ensuring compliance with regulatory requirements.
• Investigate and resolve 107+ open Deviations, with a focus on critical and major deviations (possible third-party review).
• Manage and close 187+ open CAPAs, ensuring effectiveness checks and preventive actions.
• Perform deviation criticality assessments (critical / major / minor).
• Conduct root cause analysis (RCA) using tools like 5 Whys, Fishbone, FMEA.
• Ensure timely closure of deviations while maintaining compliance with GMP guidelines.
• Assess change controls for impact on product quality, validation, and regulatory filings.
• Guarantee accurate documentation, approvals, and implementation tracking.
• Identify systemic issues leading to backlog and recommend long-term corrective actions.
• Provide training / coaching to internal teams to prevent issue recurrence.
• Ensure compliance with GMP and data integrity (ALCOA+) requirements.
• Collaborate closely with QA, QC, Manufacturing, and Regulatory teams.

Qualifications

15+ years of QA experience in the pharmaceutical sector.

Proven expertise in Change Control, Deviation, and CAPA management.

In-depth GMP knowledge (with strong Annex 11 expertise).

Experience in quality system remediation and audit readiness.

Leadership track record (Team Lead, QA Manager, Principal Consultant).

Fluency in English and French (written and spoken).

Preferred qualifications

Experience with electronic QMS (TrackWise, Veeva, MasterControl, etc.).

Lean / Six Sigma certification (Green / Black Belt).

Proven success in remediation projects with large backlogs.

Next Steps

Upon receiving your application, if a match is found, the Talent Acquisition department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.