QA Manager (m/f/d)Hessen, Frankfurt Am Main
For our client, an international pharmaceutical company in Frankfurt area, we are looking for a QA Manager (m/f/d).
- The QA Manager Projects is responsible for ensuring compliance and act as quality advocate in the CMC projects he/she is assigned.
- Specifially he/she is responsible for ensuring effective quality standards are followed within the project (CMC strategies, project plans and deliverables) and at the interface to CMOs.
- In the respective project team he/she provides quality and compliance knowledge (either by own experience or by being able to acquire the required information by their network)
- They are focal point and lead in conducting investigations and solving of quality events (OOS, deviations, RQN, technical complaints).
- Additionally they are responsible to ensure integration and application of quality risk management principles into the project
- Set-up and coordination of quality agreements with respective CMOs and contract labs.
- Full project team member in CMC team for assigned project responsible for all quality/compliance aspects
- Identification of quality/compliance risks and bringing them to the table. Definition of mitigation plan in the team and ensure follow up of agreed action plan
- establish and maintain up-to-dateProject Quality Risk Mapping
- In scientific discussion provide quality/compliance perspective
- Evaluate project proposals and scenarios taking into account technical and regulatory constraints
- In the interface to CMOs support contract negotiations related to compliance aspects, lead on compilation of quality agreements, provide audit support
- In late stage development, ensure quality aspects of work packages process characterization,
- PhD or Master in Science (University), Chemistry, Biochemistry, Biotechnology, Chemical engineering or Pharmacist
- 7+ years of professional experience in quality related roles of increasing responsibility in development and/or manufacturing of pharmaceutical products, preferable experiencewith projects in late stage development/submission and with CMO involvement
- Excellent knowledge of cGMP requirements,internal and authority guidances, quality systems and quality management systems
- Experience with outsourcing of activities and management of CMOs
- Experience as auditor is appreciated
- Fluency in English, verbally as well as in writing
Job ID: 11234
APRIORI – business solutions AG
MesseTurm 24. Etage
Tel. (069) 66 80 50-175
Fax (069) 66 80 50-400
APRIORI - business solutions AG
Atrium Tower 7. Etage