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Quality Assurance Manager (d / f / m)
Michael PageZürich (Kreis 7) Fluntern, CHVor 30+ Tagen
StellenbeschreibungMaster`s Degree or higher in Pharmacy, Microbiology, Life Sciences, or a closely related field Min 5 years experience in Quality Assurance; Quality Oversight or Regulatory Compliance, ideally in the pharmaceutical or biotech industry Solid GMP knowledge Ability to work in a cross functional team environment and to thrive in a fast-paced environment Strong communication skills in English (spoken and written); German beneficial Strong interest and commitment to digital transformation and continuous improvement through data analytics and automation is a plus Readiness to travel 1-2 a month to Germany
The QA Manager (d / f / m) will manage the Quality oversight of their external partners and continuously improve performance being responsible for the following task areas :
- GMP-compliant batch record review and approval of batch documentation as well as timely batch evaluation for externally manufactured products within the responsibility of Vaccine External Supplier Quality (ESQA)
- Preparation and approval of documents for batch release by the responsible institutes / authorities
- Management of deviations and changes as well as management and tracking of CAPA measures and other QMS documents for external products within the responsibility of ESQA
- Daily collaboration and communication with external partners, ensuring Takeda is professionally represented
- Support in coordinating complaint handling with external partners as well as with global and local functions
- Support in the preparation of inspections by regulatory authorities, as well as internal inspections and global audits at external partner
- Coordination of documents required by the regulatory department for registration purposes
- Coordination of Quality Agreements (QAGs)
- Support in the creation of global quality metrics / KPIs for external partners
In order to be considered for the role, the selected candidate must have :
The selected candidate will be part of a dynamic team and actively contribute to shape, develop, and drive the department for success! Hybrid work model (2 days onsite).