Senior Manager Quality Assurance (m/f/x)
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.
For this position, you should be open to be announced Deputy Responsible Person acc. to AMG §52a.
What will your tasks as "Senior Manager Quality Assurance (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
- Announced Deputy Responsible Person according to AMG §52a
- Close interaction with Local Authorities as well as with pharmaceutical Organizations
- Qualified Auditor for External Quality Audits (Contract Manufacturing organizations/ Contract Research Organizations) and Self-inspection according to GxP, ISO9001, HACCP, GDP, ICH Q7)
- Ensures site inspection readiness in close cooperation Business unit DAT
- Preparation, coordination and follow up on self-inspections, corporate audits and authority inspections
- Lead and manage critical quality incidents, quality alerts and recalls
- Interact with customers for quality requirements, incident handling and quality performance
- Perform business partner qualification and evaluation.
- Initiates and reviews quality improvement plan
- Reports and documents quality measures and performance
- Support and inform local business decision making from a quality perspective
- To provide QA trainings to global non-QA functions
- Set-up Quality and Technical Agreements with Distributors
- Check on availability of Whole Salers Licenses of this Distributors
- Treat complaints / deviations received from these regions via P&G complaint process and respond to the distributors
- Coordinate potential product crisis/alerts/recalls with these countries
Your requirements as "Senior Manager Quality Assurance (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
- In depth knowledge of manufacturing of medicinal products and food supplements
- 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, GDP and other relevant quality systems
- Experience in working with CMOs would be a plus
- Experience in a MATRIX organization
- Business fluency in English (oral and written); good German skills (~B1/B2)
