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Head of Quality Assurance (m/w/d)

Kötter GmbH & Co. KG Security Niederlassung Stuttgart


About us
Coriolis Pharma, is a globally operating independent service provider for formulation research and development of (bio)pharmaceutical drugs (proteins, peptides, monoclonal antibodies, RNA/DNA, etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals.

Your tasks
As Head of Quality Assurance (m/w/d) you are responsible for the continuous improvement of quality management systems at Coriolis. Your main tasks will be:

– Organization of a Coriolis wide quality management system including disciplinary responsibility for the Coriolis quality assurance unit
– Heading of the GMP QA group and coordination of GRP (Good Research Practice) QM team
– Planning and performance of internal audits for all quality relevant units
– Planning, implementation and follow-up of corrective actions resulting from audits and authority inspections
– Compilation and approval of a yearly QM status report for senior management
– Organization of QM systems for deviations, CAPAs, changes, OOS and complaints according to GMP/GRP regulations
– Securing that QM systems such as equipment qualification programs, supplier qualification and/or method validation programs are in place
– Organization and management of a system for employee training according to GMP/GRP regulations
– Establishment of a good relationship to regulatory authorities and clients, coordination and follow-up of authority inspections and client audits.
– Negotiation, approval and implementation of Quality Assurance Agreements in quality related matters
Securing the compliance according to client quality arrangements together with relevant internal stake holders (e.g., Head QC, group leaders, project managers)
– Conduction of risk analysis, deviation investigations and changes for QA related topics
– Close collaboration with BD, IT, HR GMP-QC and all operational units with respect to QM related matter
– Approval of GMP-CoA/CoTs

Details zum Stellenangebot

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