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.

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%