Site Quality Head

Job Title:  Site Quality Head

Location:  Geel, Belgium
Job Type: Permanent - full time

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About the job:

The Head of Site Quality is a senior leadership position responsible for ensuring comprehensive quality oversight and regulatory compliance across all site operations. As the site's quality authority, you will lead the quality management system, drive a culture of excellence, and ensure the site maintains valid manufacturing licenses and regulatory compliance at all times. This role operates independently from manufacturing while partnering closely with site leadership to deliver quality products that improve patients' lives.

KEY RESPONSIBILITIES

Quality Leadership & Strategy

• Develop and implement the site quality roadmap aligned with business needs and global quality objectives

• Lead the site quality management system ensuring continuous compliance and certification

• Foster a strong quality culture throughout the organization

• Ensure inspection readiness and manage regulatory inspections from health authorities (FDA, EMA, others)

Regulatory Compliance & Operations

• Ensure all activities comply with GMP/GDP regulations and Sanofi global standards

• Maintain valid manufacturing licenses and marketing authorizations

• Oversee Quality Control operations to ensure products meet specifications

• Conduct product quality reviews to verify manufacturing process consistency

• Ensure products remain compliant with approved dossiers

Continuous Improvement & Team Leadership

• Drive continuous improvement and innovation in quality systems and processes

• Lead, develop, and inspire the quality team

• Implement risk-based approaches to quality management

• Collaborate with global quality teams on system improvements

You will have decision-making authority for:

• Quality oversight of site processes and batch disposition

• Establishing site quality and compliance objectives

• Compliance actions in response to audits and inspections

• Quality strategic decisions for major projects (CAPEX, transfers, new products)

About you :

Education & Language: Bachelor's degree in Science/Engineering/Pharmacy (Master's/PhD preferred); fluent in Dutch and English (written and spoken)

Experience: Minimum 10 years in pharmaceutical quality management; experience with multiple product types and new product launches preferred

Regulatory Expertise: Deep knowledge of GMP/GDP regulations (ICH, FDA, EMA); proven track record managing regulatory inspections

Technical Skills: Expert in pharmaceutical regulations, manufacturing processes, inspection readiness, and quality risk management

Leadership: Demonstrated experience in quality leadership roles; ability to develop high-performing teams and manage stakeholders

Strategic Thinking: Strong decision-making skills under uncertainty; change management and project management expertise

Core Behaviors: Results-oriented, collaborative, innovative, with a focus on continuous improvement and commitment to quality excellence and patient safety

POSITION SCOPE

• Site Headcount: approx. 800 employees  

• Quality Team Size: approx. 200  employees 

• The Geel site produces therapeutic proteins from cell culture for biological medicines (i.e. monoclonal Antibodies and Enzymes)

• Regulatory Markets: Local to global (FDA, EMA, and others)

WHAT WE OFFER

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.

PursueProgress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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

#LI-BE

#LI-Onsite