Regulatory Et Inspection Readiness Expert

vor 5 Monaten

CorsiersurVevey, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
Site Regulatory compliance activities:

- Ensure Quality/CMC consistency and compliance by liaising with the Global Regulatory Affairs department. You will support the establishment of Regulatory reporting (e.g. Annual Reports) and Regulatory Affairs requests (e.g. renewals process, statements, GMP certificates).
- be involved in the Change Control Proposals (CCPs) from a regulatory perspective.
- Provide the regulatory status overview for products portfolio to the Qualified Person of the site in the frame of product disposition process.

Inspection Readiness activities:

- Lead the site Quality inspections readiness program, from notification by the inspection body until approval of the CAPA plan
- Central member of the audit/inspection hosting team
- Coordinate and follow-up the definition and execution of CAPA plans

**Who you are**:

- Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- You have at least 5-7 years of experience in the pharmaceutical industry
- You have at least 5 years of experience in global CMC regulatory affairs, and quality assurance / compliance, inclunding experience in inspection readiness.
- Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, or International)
- Good knowledge in biotechnological sciences, manufacturing of biologics and related regulatory guidelines (cGMPs, 21 CFR, etc.)
- Excellent written and spoken communication skills in English

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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