Quality Compliance Head Europe - Specialty Care (all genders)

卡湯晩; Frankfurt; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Quality Compliance Head for Manufacturing & Supply Specialty Care. In this pivotal role, you'll oversee cGMP compliance, manage health authority interactions, and lead regulatory projects across a network of sites. Your expertise in pharmaceutical regulations and Biologics Operations will be crucial in ensuring inspection readiness and driving a culture of quality and continuous improvement. Join a forward-thinking company dedicated to enhancing healthcare outcomes and making a meaningful impact in the industry. This position offers a unique opportunity to collaborate with global quality experts and contribute to transformative initiatives.

Qualifikationen

• Advanced knowledge of pharmaceutical and medical device regulations.
• In-depth experience of Biologics Operations and interacting with health authorities.

Aufgaben

• Lead cGMP compliance projects and support inspection readiness.
• Champion quality culture and continuous improvement across all levels.

Kenntnisse

Regulatory expertise

Project management proficiency

Strong analytical capabilities

Quality & Risk Management experience

Continuous improvement methodologies

Business partnering and stakeholder management

Excellent communication and networking abilities

Influential and change-oriented mindset

Customer-focused approach

Strategic thinking

Ausbildung

Pharmacy degree or equivalent

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

Tools

Digital tools and new technologies

Jobbeschreibung

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.