Job detail for Compliance Expert - Head of Manufacturing Aseptic Production

About the role

We work with modern isolator systems for the production and filling of sterile injectable preparations. Our department is characterized by versatile processes and workflows. We are convinced that we ensure the best quality and a secure supply of life-saving medicines for our patients at all times. For us, the well-being of our patients is the highest priority! Become part of our team, which is characterized by a high sense of responsibility and strong cohesion! We look forward to reinforcements to ensure we can continue to provide for our patients safely in the future. Ready for your start?

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by turning impossible into the possible for patients. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

**Main **

• Execution and assurance of proper manufacturing and testing in accordance with national and international regulations, and assuming responsibility for the safety and quality of medicinal products and medical devices, as well as confirming that the necessary documentation is complete as Head of Manufacturing (if already appointed)
• Ensuring compliant production and proper storage of medicinal products to maintain the required quality
• Ensuring and monitoring compliance with GMP and quality guidelines. Development and implementation of quality-enhancing measures, as well as initiation of countermeasures in case of deviations
• Development of procedures for the manufacture of medicinal products and development and application of pharmaceutical technology testing methods for the and assurance of pharmaceutical quality
• Ensuring GMP compliance of manufacturing and testing processes, including process validation
• Transfer of research and development results into industrial routine operation
• Training of personnel in the areas of manufacturing, testing, and storage of medicinal products
• Responsible for compliance with product-related SOPs and their updates
• Creation and training of processing protocols
• Ensuring the control of maintenance, premises, and equipment
• Batch release as Head of Manufacturing

About you

Education:

• Completed university degree in pharmacy, biotechnology, molecular sciences, chemistry, biology, or comparable fields (State Examination, Diploma, Master's), preferably with a doctorate

Experience:

• Experience as Head of Manufacturing is desirable

Social skills / Technical skills:

• Comprehensive cGMP knowledge and experience in working with cGMP
• Proficient in MS-Office and other IT skills
• Independent, responsible, and meticulous way of working according to GMP requirements
• Very good knowledge in the area of performance optimization and harmonization of systems
• Flexibility and commitment due to diverse tasks
• Ensuring the execution of necessary validations

Languages:

• Very good German and English skills

Why should you choose us?

• Discover the miracles of science with an innovative team to improve human health.
• Find diverse opportunities in an international work environment to develop your talent professionally and personally and to continuously advance your career through internal moves and role expansions. Individual and structured onboarding is a matter of course and begins even before your first day.
• An attractive, market-oriented compensation and benefits package, including a company pension scheme, rewards your experience and contribution.
• We take care of you and your family with a wide range of health and social benefits such as high-quality healthcare, many prevention programs, free vaccinations, and protection in case of long-term illness. Outstanding is our 14-week paid family leave after the birth of a child for both parents, as well as other diverse support for childcare and the care of relatives.

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!

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.