Senior Manager, Eu Qualified Person Commercial Products

BeOne Medicines Ltd

Remote
Base: 100,800.00 eur - 126,000.00 eur; bonus/equit...
Eu gmp annex 16
Manufacturing and import authorization
Quality management system
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

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 our passionate interest in fighting cancer.

Matching 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.

Salary

Base: 100,800.00 EUR - 126,000.00 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • EU GMP Annex 16
  • Manufacturing and Import Authorization
  • Quality Management System
  • European Directive 2001/83/EC
  • batch certification
  • regulatory compliance inspections

Nice-to-have

  • fighting cancer
  • collaborative
  • highly motivated
  • scientific and business professionals
  • sense of urgency
  • German is a plus

Key Requirements

  • Pharmacist/MSc or Scientist recognized by Regulatory Authority
  • minimum of 3 years of experience
  • Experience as a QP
  • In-depth GMP experience
  • Fluent in Dutch, English (C2)

Work Rights

Not specified

Tailored Resume

Cover Letter