Qms Expert

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.

As an integral member of our Site Quality Darmstadt Development Unit, you will be accountable for site regulatory compliance activities, provision of manufacturing and import authorization documents. In addition, you will be involved in site Supplier/CDMO management activities.

**Your role**:

- Review and update of change controls in the context of the manufacturing and import authorization
- Maintaining Site Master File, prepare and update related SOPs
- Supplier / CDMO management including qualification and monitoring, negotiation of QTAs
- Review & Tracking of CDMO GMP licences and QP Statements
- Representative towards Interfaces regarding regulatory compliance topics

**Who you are**:

- Biologist, pharmacist or other Life Science-related discipline, PhD advantagous
- 3-5 years experience in pharmaceutical industry, training or education or experience in regulatory environment; supplier management experience advantageous
- Fluently spoken and written English and German
- Good editorial and communication skills
- Organisation, structure and coordination
- Ability to be purposeful, result-driven and collaborative.

**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