Senior Manager, Quality Assurance

4 weken geleden

Zwolle, Overijssel, Nederland BeiGene Voltijd
Job Title: Senior Manager, Quality Assurance

BeiGene is seeking a highly motivated and experienced Senior Manager, Quality Assurance to join our team. As a key member of our Global Compliance organization, you will be responsible for ensuring the regulatory compliance status of BeiGene and our vendors.

Key Responsibilities:
  • Execute the external vendor audit program to ensure compliance with global regulatory requirements.
  • Lead/participate in GMP/GDP compliance audits to identify gaps or risks and develop corrective actions.
  • Develop and manage audit reports and quality events.
  • Support GMP/GDP Health Authority Inspections and maintain compliance audit trends and metrics.
  • Develop and maintain SOPs and work instructions pertinent to the External vendor audit program.
Requirements:
  • Bachelor's degree in science or professional certifications.
  • 10+ years of experience in the pharmaceutical/biotechnology industry.
  • 5+ years of GMP/GDP QA experience, including management experience and certification as a quality auditor (CQA).
  • Knowledge and understanding of current US and EU Good Manufacturing Practices (GMP) Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.
  • Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
What We Offer:
  • A dynamic and challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.
How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information].

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