Quality Compliance Head Europe - Specialty Care (all genders)

About the Job

As Quality Compliance Head for Manufacturing & Supply Specialty Care GBU, you will provide critical oversight of cGMP compliance across our network. You'll support sites in inspection readiness, manage health authority interactions, and assess implementation of Sanofi's Quality Management Systems in accordance with company and regulatory requirements.

You will lead cGMP Regulatory & Compliance projects through transversal activities across our site network. This role serves as a vital link between Site Quality Units, the M&S SpeCare GBU Quality Unit, and Global Operational Quality Units.

Key Responsibilities

Lead cGMP compliance projects aligned with M&S SpeCare GBU Quality Operations strategy

Support inspection readiness through quality system assessments and gap identification

Guide external inspection preparation, management, and health authority responses

Review effectiveness of sites' Quality Systems during visits and interactions

Contribute to Global Quality Dashboard reporting for management visibility

Coordinate IRISC activities for the M&S SpeCare GBU

Champion quality culture and continuous improvement across all organizational levels

Support training initiatives on Sanofi Global Quality System and regulatory requirements

Facilitate knowledge sharing through webinars and best practice exchanges

Provide quality risk management support and contribute to Risk Management Reports

Participate in digital transformation initiatives aligned with Global Quality strategy

Collaborate with quality experts across GBUs and global quality functions

About You

Experience:

Advanced knowledge of pharmaceutical and medical device regulations

In-depth experience of Biologics Operations

Deep experience in interacting with health authorities (FDA, ANSM)

sound knowledge/experience in Biologics

Education:

Pharmacy degree or equivalent

Master's Degree in Pharmaceutical Technology, Life Sciences or Engineering

Languages:

Fluent in English

additional French language knowledge welcome – but not a must

Technical Skills:

Regulatory expertise

Project management proficiency

Strong analytical capabilities

Quality & Risk Management experience

Continuous improvement methodologies

Knowledge in digital tools and new technologies

Soft Skills:

Business partnering and stakeholder management

Excellent communication and networking abilities

Influential and change-oriented mindset

Customer-focused approach

Transversal collaboration

Results-driven with decision-making capabilities

Strategic thinking

Location: Gentilly, France or Frankfurt, Germany

Work Arrangement: up to 40% Remote working option

Travel: 20% expected

Position Type: Permanent, Full-time

Pursue Progress. Discover Extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue

progress, discover

extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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