Quality Director

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.

Relocation Assistance: This role is eligible for relocation support for French-speaking candidates relocating from within France or other European countries.

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%