(Senior) Quality Assurance Manager (m/f/x) | Frankfurt area | Pharma
In this position you will be mainly responsible for overseeing all QA activities on a global level. You will be in close contact with local authorities as well as with pharmaceutical organizations. Participation in internal and external audits will be another key role alongside tasks such as leading and managing critical quality incidents, quality alerts and recalls, reporting and documentation as well as providing QA trainings. Another main task will be to make sure, QMS is compliance with all current laws and rules, GxP guidelines as well as with external requirements and corporate internal standards.
What will your tasks as "(Senior) Quality Assurance Manager (m/f/x)" be?
- Overseeing QA activities for all activities of DAT legal entities
- QMS should be compliant with all current local laws and rules, GxP guidelines, external requirements and corporate internal standards for medicinal products, food supplements, cosmetics, and medical devices) and lean
- Implementation, preparation, and participation in internal and external audits
- Preparation, revision and review of SOPs, deviations, changes, CAPAs and other QA-relevant documents
- Supplier qualification incl. planning of necessary audits
- Ensuring compliance with relevant laws and guidelines
- Participation in projects or taking over sub-projects in the area of quality assurance
- Cooperation with other departments regarding quality-relevant topics
Your requirements as "(Senior) Quality Assurance Manager (m/f/x)"?
- University degree in a life-sciences field
- Several years of experience in the pharmaceutical industry with a focus on Quality Management / QA
- Broad understanding of the drug development process and regulatory environment and experience with implementing QMS and processes in a regulatory environment
- Good knowledge of GMP and GDP / experience with GxP and FDA would be a plus
- Experience in working with CMOs would be a plus
- Business fluency in English and German (oral and written)
I look forward to your application!