Senior Manager, Eu Qualified Person Commercial Products

Beonemedicines Com Au

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Eu qp certification
Gmp compliance
Manufacturing and import authorization
** BeOne Medicines is seeking a Senior Manager, EU Qualified Person for Commercial Products, responsible for certifying finished medicinal products in compliance with EU regulations. The ideal candidate will have a strong background in pharmaceutical quality assurance, regulatory compliance, and a passion for cancer treatment. **

Job Summary

  • The Qualified Person (QP) Commercial Products is responsible for ensuring that each finished medicinal product batch has been manufactured and shipped in accordance with GMP, the terms of the MIA, the MA or made for export as per European Directive 2001/83/EC.
  • The incumbent will report to the Director, Distribution & Regional Quality, Europe Commercial Quality Head and ideally also qualifies as a Responsible Person GDP.
  • BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals who share a passionate interest in fighting cancer.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Manager, EU Qualified Person for Commercial Products, responsible for certifying finished medicinal products in compliance with EU regulations. The ideal candidate will have a strong background in pharmaceutical quality assurance, regulatory compliance, and a passion for cancer treatment. **

Skills & Requirements

Must-have

  • EU QP certification
  • GMP compliance
  • Manufacturing and Import Authorization
  • Quality Management System
  • European Health Authority regulations

Nice-to-have

  • Collaborative spirit
  • Passionate interest in fighting cancer
  • Entrepreneurial mindset
  • Self-awareness
  • Acts inclusively

Key Requirements

  • Pharmacist/MSc or Scientist recognized by Regulatory Authority for QP status
  • Minimum 3 years experience in healthcare/pharmaceutical/biotechnology
  • Experience as a QP in pharmaceutical or biotech industry
  • In-depth GMP experience
  • Fluent in Dutch and English (C2)

Work Rights

Not specified

Tailored Resume

Cover Letter