Quality Director
- Company: Thermo Fisher Scientific
- Location: Bourgoin Jallieu Cedex, France
- Work mode: On-site
- Job type: Full-Time
- Posted: 2026-09-17
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
QUALITY SITE DIRECTOR (QP) – OSD MANUFACTURING
Location: Bourgoin, France (Site-Based)
Business: Pharma Services Group (PSG) – Drug Product Division (DPD) | CDMO
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Within our Pharma Services Group (PSG), we partner with pharmaceutical and biotech companies to accelerate drug development and deliver life-changing therapies worldwide.
We are seeking an experienced and strategic Quality Director (Qualified Person) to lead the Quality organization at our Bourgoin OSD (Oral Solid Dose) manufacturing site. This is a critical leadership role within a global CDMO environment, combining regulatory authority, operational excellence, and people leadership.
As a member of the Site Leadership Team, you will hold full accountability for the Quality Management System, regulatory compliance, and oversight of QA, QC, and laboratory operations — ensuring the highest standards of quality, patient safety, and inspection readiness.
KEY RESPONSIBILITIES
* Lead the full site Quality organization (QA, QC, Compliance, Validation, Quality Systems)
* Act as the registered Qualified Person (QP) for the site
* Ensure compliance with French, EU, FDA, and global regulatory standards
* Lead regulatory inspections and manage interactions with ANSM, EMA, FDA, and other authorities
* Drive a proactive quality culture with strong risk-based decision-making
* Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness
* Support NDA submissions and regulatory filing activities
* Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality
* Develop and lead a large, multi-layered Quality organization (8–10 direct reports; 100+ indirect)
* Champion continuous improvement initiatives (PPI, Lean, DMAIC, 8D)
QUALIFICATIONS & EXPERIENCE
KEY REQUIREMENTS
* French Pharmacist degree enabling registration as a Qualified Person (QP)
* Fluent in French and English
* 10+ years’ senior Quality leadership experience within regulated pharmaceutical manufacturing
* Proven experience managing both QA and laboratory operations
* Experience operating as a Site Quality Lead and member of a site leadership team
* Strong experience leading regulatory inspections (French and international authorities)
* Experience within an industrial GMP manufacturing environment (OSD preferred)
* Experience supporting or managing NDA submissions
PREFERRED
* CDMO experience with client-facing quality governance
* Lean / Six Sigma or operational excellence background
TECHNICAL EXPERTISE
* Deep knowledge of EU GMP, FDA CFR, and global regulatory frameworks
* Strong command of CAPA systems, deviation management, and change control
* Advanced application of quality methodologies (FMEA, SPC, risk management, 8D, DMAIC)
Travel required 25-30%