TRIGA EXKLUXIVMANDAT:
For our client (which specializes in the development and commercialization of innovative antibody therapies) we are searching for a:
Head of GMP Compliance PR (m/f/d) to lead the GMP Compliance group in production and ensure our high-quality standards.
Aufgaben
* Professional and disciplinary leadership of the GMP Compliance group in production
* Ensuring compliance with all GMP requirements and quality standards, including documentation (batch documentation, SOP management, change control, deviation management, CCS strategy)
* Responsibility for training and personnel qualification in GMP-related topics (e.g., hygiene and process behavior)
* Coordination of statistical evaluations in production and initiation of supplier qualifications
* Support in adapting manufacturing documentation and contract management for the production department
* Acting as an interface to the quality management department
Qualifikation
* Completed degree in biotechnology, pharmacy, biochemistry, or a comparable field
* Several years of professional experience in pharmaceutical manufacturing and GMP-compliant documentation
* Indepth knowledge of regulatory requirements for the production of biologics
* Experience with quality systems, ideally with initial leadership experience
* Structured, precise, and reliable working style with strong team orientation
* Very good English skills (minimum CEF B2) and solid MS Office proficiency
Benefits
* A varied role in an innovative biotech company with room for creativity and short decision-making processes
* Flexible working hours with a flextime model (37.5 hours/week)
* 30 days of vacation
* Comprehensive social benefits
Interested? We look forward to receiving your application!
Mariana Chaumont
Senior Consultant089-8091307-20
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