QA Manager

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

Résumé du poste

PQE Group is seeking a highly experienced QA Manager to join our leading organization in the Pharmaceutical and Medical Device industries. This role involves addressing a significant backlog in Quality Systems, ensuring compliance with GMP guidelines, and leading a team in quality system remediation efforts. If you have over 15 years of experience in QA, particularly in change control and deviation management, and are fluent in both English and French, we invite you to apply and join our multicultural team.

Qualifications

• 15+ years of QA experience in pharma/biotech.
• Leadership skills in previous roles.
• Fluent in English and French.

Responsabilités

• Review and close 700+ open Change Controls.
• Investigate 107+ open Deviations.
• Manage and close 187+ open CAPAs.

Connaissances

Quality System Remediation

Root Cause Analysis

Process Improvement

Change Control Management

Deviation Management

CAPA Management

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 :

We are seeking a highly experienced QA Manager to support our client in resolving a significant backlog in 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.

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 (may require third-party review).
• Manage and close 187+ open CAPAs, ensuring effectiveness checks and preventive actions.
• Perform criticality assessments of deviations (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.
• Evaluate change controls for impact on product quality, validation, and regulatory filings.
• Ensure proper 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 recurrence.
• Ensure alignment with GMP, and data integrity (ALCOA+) requirements.
• Work closely with QA, QC, Manufacturing, and Regulatory teams.

Qualifications :

• 15+ years of QA experience in pharma / biotech
• Expertise in Change Control, Deviation, CAPA management.
• Strong knowledge of GMP (with strong expertise in Annex 11)
• Experience in quality system remediation and audit readiness.
• Leadership skills (previous Team Lead, QA Manager, or Principal Consultant roles).
• Fluent in English and French (written & spoken).

Preferred qualifications :

• Experience with electronic QMS (TrackWise, Veeva, MasterControl, etc.).
• Lean / Six Sigma certification (Green / Black Belt).
• Previous experience 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 a 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.