Ingénieur(e) mécanique confirmé(e) f/h

MBDA France; Le Plessis-Robinson; Hybride; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a Quality Compliance Head for Manufacturing & Supply Specialty Care. This pivotal role involves overseeing c GMP compliance across a network, managing health authority interactions, and driving quality culture and continuous improvement. You will lead regulatory projects, support inspection readiness, and collaborate with quality experts globally. If you have a strong background in pharmaceutical regulations, a strategic mindset, and a passion for quality, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• Advanced knowledge of pharmaceutical and medical device regulations.
• In-depth experience of Biologics Operations and health authority interactions.

Responsabilités

• Lead c GMP compliance projects aligned with Quality Operations strategy.
• Support inspection readiness through quality system assessments.

Connaissances

Regulatory expertise

Strong analytical capabilities

Quality & Risk Management experience

Knowledge in digital tools and new technologies

Business partnering and stakeholder management

Excellent communication and networking abilities

Influential and change-oriented mindset

Customer-focused approach

Results-driven with decision-making capabilities

Strategic thinking

Formation

Pharmacy degree or equivalent

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

Description du poste

Quality Compliance Head Europe - Specialty Care (all Genders)

AsQuality Compliance Headfor Manufacturing & Supply Specialty Care GBU, you will provide critical oversight of c GMP 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 c GMP Regulatory & Compliance projects through transversal activities across our site network. This role serves as a vital link between Site Quality Units, the M&S Spe Care GBU Quality Unit, and Global Operational Quality Units.

Key Responsibilities

• Lead c GMP compliance projects aligned with M&S Spe Care 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 Spe Care 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:

• additional French language knowledge welcome – but not a must

Technical Skills:

• Regulatory expertise
• Strong analytical capabilities
• Quality & Risk Management experience
• 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
• 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.

Occupation: Quality compliance head europe - specialty care (all genders)

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