Implementation Expert (all Genders) - Befristet Auf 2 Jahre

Biotech Compliance Manager

We are a research-driven biopharma company that applies AI to improve lives and grow responsibly. Our deep understanding of the immune system and our innovative pipeline enable us to develop medicines and vaccines that treat and protect millions of people worldwide. Together we explore the wonders of science to improve lives.

Main Responsibilities:

• Planning, timely implementation, and development of measures or projects to improve compliance with the requirements of contamination control of biologics
• Coordination of concepts, design, and implementation strategy with the operation and the Bio2.0 program, taking into account the production and downtime activities of a biopharmaceutical production
• Planning and implementation of HSE and operational requirements in the project
• Supporting documentation and handling of deviations, change controls, CAPAs, and technical reports derived from the project
• Supporting the planning and execution of potential process transfer, qualification, and validation activities
• Supporting the creation, adaptation, and review of project and operational documents
• Training of newly created or updated manufacturing documentation and SOPs
• Communication with supervisors, employees, and colleagues in a multidisciplinary environment
• Participation in internal and external inspections as an expert in the context of BLA topics including inspection-specific planning, organization, and coordination with interfaces

About You:

• Completed higher education in biology, biotechnology, chemistry, engineering or equivalent training
• Experience in biopharmaceutical production and drug development or manufacturing is desirable
• Experience with the qualification and validation of pharmaceutical facilities
• Knowledge of international requirements for the production of active substances (focus on biologics), US/EU GxP regulations

Social Skills / Technical Skills:

• Comprehensive GMP and HSE knowledge and didactic skills
• Independent, self-reliant, and meticulous work according to GMP requirements
• Enjoyment of working in interdisciplinary teams
• Team player with excellent communication skills
• Flexibility and resilience due to diverse tasks
• Strong sense of responsibility and quality-oriented action
• Performance readiness and assertiveness

• Ability to question the status quo and propose alternatives (critical/unconventional thinking)
• Good knowledge in the field of quality risk management (e.g. FMEA)
• Good knowledge in the use of database applications, MS Office applications, and Q-Systems
• Good knowledge in project management and change management is an advantage

Languages:

• Very good German and English skills in speech and writing

Why should you choose us?

• Discover the wonders of science with an innovative team to improve the health of people.
• Find diverse opportunities in an international work environment to develop your skills and advance your career through internal changes and role expansions. Individual and structured training is of course, and starts before the first day.
• An attractive, market-oriented compensation and benefits package including a company pension plan, honors 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 health care, many prevention programs, free vaccinations, and coverage in case of long-term illness. Outstanding is our 14-week paid parental leave after the birth of a child for both parents as well as further diverse support in childcare and care of relatives.

Pursue Progress. 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.