Quality Director

thermofisher· Patheon France SAS
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📍 Bourgoin-Jallieu, FranceFull time

About this role

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%

Frequently Asked Questions

Is the salary disclosed for the Quality Director position at thermofisher?
The salary for this Quality Director role at thermofisher is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Quality Director position at thermofisher located?
This Quality Director role at thermofisher is based in Bourgoin-Jallieu, France. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Quality Director role at thermofisher full-time or part-time?
This is listed as a Full time position. It is posted as a Quality Director role in the Patheon France SAS department at thermofisher.
Which team or department does the Quality Director at thermofisher belong to?
This Quality Director position is part of the Patheon France SAS department at thermofisher. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality Director position at thermofisher?
Click the "Apply Now" button on this page. You will be redirected to thermofisher's official application portal hosted on workday where you can submit your application directly.
When was the Quality Director job at thermofisher posted?
This Quality Director position at thermofisher was posted on Sep 17, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Director
thermofisher
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