München: Head of GMP Compliance PR (m/f/d) - Pharma - München

apartmentTriga Consulting GmbH & Co KG placeMünchen calendar_month 

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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