About the job

Our Team:

SFB&O is an Industrialization & Launch Site for new Biologics within the Manufacturing & Supply (M&S) Specialty Care network. The site is responsible for implementation & launch of new products and production of existing legacy products. It is also supporting the Specialty Care Network with QC testing according to the Analytical Lead Site concept.

The site is in transformation to a fully integrated End-to-End (E2E) site with the implementation and start-up of a new Microbial Launch Plant for the production of Drug Substance and the transition of the CAPI facility to M&S to cover drug substance and drug product manufacturing.

A huge part of the site activities will be industrialization of new product in Drug Substance and Drug Product, supporting R&D clinical supply.

Main responsibilities:

• Providing quality leadership and oversight across the site SFB&O
• Responsible for quality assurance, quality control and regulatory across SFB&O organization including the End-to-End (E2E) approach covering drug substance manufacturing and drug product manufacturing. QC department activities do also include contract testing for other manufacturing sites in the Sanofi network, e.g. release testing of the top-seller Dupixent.
• Assurance of a sustainable compliance of the site with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements. Assurance of the most effective use of the available resources for quality assurance and quality control.
• Development of the site Quality system into an integrated highly efficient system as a foundational element for the E2E SFB&O launch site.
• Ensure readiness for inspection by national and international agencies through implementation and maintenance of a quality organizational unit and quality systems, complaint to cGMP
• Recruit, develop and lead Quality staff in accordance with established leadership principles. Build and maintain an effective and efficient organization and revise if deemed necessary.
• Responsible for development of site strategy and cultural change as member of the site leadership team
• Securing that Qualified Persons according to legal requirements are implemented to manage oversight and release process in compliance with current GMP

About you

Education and professional Experience

• Scientific degree in science, medicine, engineering or Pharmacy
• Minimum 5 years Leadership experience in Quality at an industrial (Pharma is preferred) site
• Practical and solid experience of minimum 10 years in Quality System Management in health-regulated industry.
• GxP and health-related regulations knowledge in production and development of active substances and drug product.
• Knowledge in Auditing, Process validation, Quality Assurance, Quality Control, Regulatory Affairs, Quality Risks Management, Quality Systems domains.
• Experience in leading organisations, Negotiation, Project Management, Networking and Problem Solving
• Qualification as Qualified Person (optional)
• International exposure
• FDA exposure

Soft skills

• Leadership: change management. Team spirit. Develop People. Transversal cooperation – customer committed
• Driver of change: willing to challenge “conventional” thinking and ways of working – striving for results
• Ability for strategic thinking and having predictions for Quality evolution.

Languages

• English speaking required as main vehicle or international transversal and external communication (written & verbal)
• German language knowledge required as main vehicle for site management

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, disability, or gender identity.

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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.