Quality Compliance Head Europe - Specialty Care (all genders)

Sanofi EU; Gentilly; 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 cGMP compliance across their network, managing health authority interactions, and implementing robust Quality Management Systems. You will lead compliance projects, support inspection readiness, and champion a culture of quality and continuous improvement. This position offers a dynamic work environment with opportunities for digital transformation and collaboration across global quality functions. Join a team dedicated to making a difference in the pharmaceutical landscape.

Qualifications

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

Responsabilités

• Lead cGMP compliance projects aligned with M&S SpeCare GBU Quality Operations strategy.
• Support inspection readiness through quality system assessments and gap identification.

Connaissances

Regulatory expertise

Strong analytical capabilities

Quality & Risk Management experience

Knowledge in digital tools and new technologies

Formation

Pharmacy degree or equivalent

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

Description du poste

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 :

• 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

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