About the role
The Compliance Expert is responsible for ensuring that the manufacturing of medicinal products is carried out according to previously established written instructions and standard operating procedures (manufacturing instructions), which must comply with the valid marketing authorization documents. They are further responsible for ensuring that the execution of these instructions is in accordance with Good Manufacturing Practice (GMP) as well as recognized pharmaceutical rules (AMWHV, EU Eudralex, WHO, PIC/S, US CFR, etc.).
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 working to turn the impossible into the possible. 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.
Key responsibilities
Within the scope of their role, they are also specifically responsible for the following points or ensures that:
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Products are stored in accordance with regulations
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Approval and compliance with manufacturing instructions are in place
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Only components manufactured according to GMP rules are used and all starting materials meet valid specifications
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Independent execution and creation of qualification and validation
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Maintenance of premises and equipment for manufacturing meets requirements
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Necessary validations and revalidations of manufacturing processes are in place
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Necessary qualifications and calibrations of the technical equipment used are in place
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Required initial and ongoing training of personnel working in the manufacturing area is conducted
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Process deviations or changes are processed accordingly within the framework of a Q-system
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Manufacturing documentation complies with current regulatory requirements and the manufacturing of each batch is carried out according to the manufacturing instructions, is fully documented, and signed by the Head of Manufacturing (batch record)
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Product Quality Reviews are reviewed and approved
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Operational process flows comply with generally accepted GMP requirements
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Ensuring that all operational procedures comply with relevant regulations (FDA, EMA, ICH) and international standards
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Preparation for and participation in internal/external audits and regulatory inspections
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Identifi cation of potential compliance risks and development of mitigation strategies
About you
Experience:
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Relevant professional experience in the pharmaceutical environment as well as sound knowledge and practical experience in the areas of:
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Qualification and validation of equipment as well as creation of associated documentation
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Management of complex change processes
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SAP systems (ideally SAP ERP, SAP S/4HANA or comparable modules)
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Packaging processes and management in the pharmaceutical industry
Soft skills / Technical skills:
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Independent, structured, and solution-oriented way of working
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Very good communication skills and ability to work in a team
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Proficient handling of MS-Office/ SAP and further IT skills
Education:
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Completed degree in a technical or scientific field (e.g., Chemistry, Biology, Pharmacy, Biotechnology, Process Engineering, Engineering) or a comparable professional qualification
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Alternatively: Relevant practical experience and proven professional competence in a related field
Languages:
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German
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English, spoken and written (business fluent)
Why should you choose us?
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Discover the wonders of science with an innovative team to improve human health.
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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.
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An attractive, market-oriented compensation and benefits package, including a company pension scheme, rewards your experience and contribution.
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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 :
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.