Quality Validation Manager IFF (all genders)

Sanofi Group; Frankfurt; On-site; EUR 81,000 - 121,000; Full time

Benefits offered by this job

Company employee benefit programs

Job summary

Sanofi in Frankfurt is seeking a Quality Validation Manager IFF to lead Quality Qualification and Validation activities across the project lifecycle, from design through commissioning, ensuring compliance with GMP, QbD concepts, and global standards.

As Quality SME, you will write, review and release documentation, support QMS enhancements, and collaborate with sites in China and other teams to uphold benchmark quality.

Qualifications

• Masters or Diploma in Science, Pharmacy or equivalent.
• Experience in biopharma or regulated industry preferred.
• Knowledge of biologic product license (BLA) process and regulatory requirements.

Responsibilities

• Lead project quality qualification and validation activities per GMP.
• Act as Quality SME for the project on qualification and validation.
• Develop and update QMS initiatives to maintain compliance.
• Collaborate with international teams to align standards.
• Ensure documentation turnover packages are consistent.

Skills

German language

English language

Quality systems

Education

Masters/Diploma Degree in Science, Pharmacy or Equivalent

Job description

About the job

Be part of a once‑in‑a‑generation project that’s shaping the future of insulin. Sanofi is building a cutting‑edge, fully automated insulin drug substance facility in Frankfurt – a bold investment that builds on our legacy of excellence in insulin manufacturing. This sustainable, next‑gen biologics site will support the entire portfolio of insulins, from development to delivery. Join us at the forefront of this global transformation. As part of a cross‑functional program team, you’ll help bring this facility to life – from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes. Meet Katrin, our Global Insulin Program Leader, and see how we’re reimagining insulin production. Watch now!

Position overview

The Quality Validation Manager IFF is responsible for ensuring that all aspects of Quality Qualification and Validation activities for the project are executed on time and in accordance with the project, local and global requirements, and applicable regulations. As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of all qualification and validation strategies and providing support and guidance for quality processes and procedures. This role is expected to work independently and with a level of autonomy and authority in decision‑making to ensure on‑going compliance against approved documents and current Good Manufacturing Practices across the project during technical detailed design, construction, C&Q, PQ, validation phases and future site organizations until final approval within worldwide dossiers.

Main responsibilities

• Ensure quality culture, mindset, GMP compliance performance and continuous improvement across all functions and organizational levels across the project and future sites.
• Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Qualification and Validation, ensuring quality compliance in project execution.
• Deliver Quality activities in accordance with IFF planning & project needs, including writing, reviewing and releasing documentation considering QbD approach as required.
• Contribute to the improvement of QMS initiatives to ensure compliance with applicable regulatory requirements and Sanofi quality standards at all times.
• Develop, update and promote Sanofi Global Quality Documentation and IFF GOPs or Global procedures.
• Ensure the consistency of turnover packages to system owners.
• Support execution of project Qualification, Validation strategy and plans as required whilst Collaborate with the facility in China to maintain benchmark standards and share best practices.
• Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Validation deliverables.

About you

Education/Experience: Ideally Masters/Diploma Degree in Science, Pharmacy or Equivalent; relevant experience within the industry, preferably within biopharma and/or related regulated industry, preferably in Insulin DS processes; In‑depth knowledge of biologic product license (BLA) application registration process, and the associated regulatory requirements.

Soft and technical skills

• Act for Change
• Cooperate transversally
• Decision making
• People Development
• Thoughtful‑Risk‑Taking mindset
• Negotiation and Influential skills
• Business Partnering
• Communication skills (English)
• Leadership and assertiveness skills
• experience with Quality systems, Qualification & Validation activities (e.g. Cleaning Validation, Filter Validation, Analytical Validation), Continuous improvement management, GxP and health‑regulated expertise, international and FDA exposure

Languages

• proficiency in German and English required

Company culture

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, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Salary & benefits

The salary range for this position is :€80.724,00 - €121.068,00. Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefit programs.

About Sanofi

We are an R&D driven, AI‑powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie. We are Sanofi. Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug‑discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.