Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Quality Director

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBourgoin-Jallieu, FranceNo salary listedIn-person

About the Job

Requirements

A French Pharmacist degree enabling registration as a Qualified Person (QP) is required.
Fluency in French and English is required.
At least 10 years of senior Quality leadership experience within regulated pharmaceutical manufacturing is required.
Experience managing both Quality Assurance and laboratory operations is required.
Experience operating as a Site Quality Lead and as a member of a site leadership team is required.
Strong experience leading regulatory inspections with French and international authorities is required.
Experience in an industrial Good Manufacturing Practice (GMP) manufacturing environment is required; Oral Solid Dose (OSD) experience is preferred.
Experience supporting or managing New Drug Application (NDA) submissions is required.
Deep knowledge of EU GMP, FDA Code of Federal Regulations, and global regulatory frameworks is required.
Strong command of Corrective and Preventive Action (CAPA) systems, deviation management, and change control is required.
Advanced application of Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), risk management, 8D, and Define, Measure, Analyze, Improve, Control (DMAIC) methodologies is required.

Responsibilities

Lead the full site Quality organization, including Quality Assurance, Quality Control, Compliance, Validation, and 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 risk-based decision-making.
Oversee CAPA, deviations, change control, complaints, validation, and inspection readiness.
Support New Drug Application (NDA) submissions and regulatory filing activities.
Partner cross-functionally with Operations, Supply Chain, Technical, and Global Quality teams.
Develop and lead a large, multi-layered Quality organization with 8–10 direct reports and 100+ indirect reports.
Champion continuous improvement initiatives using PPI, Lean, DMAIC, and 8D.

Desired Qualifications

CDMO experience with client-facing quality governance is preferred.
A Lean, Six Sigma, or operational excellence background is preferred.

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%

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size: 10,001+
Company stage: IPO
Headquarters: Waltham, MA
Founded: 1956

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