Senior Manager Regulatory Affairs Specialist

4 weeks ago

Cambridgeshire and Peterborough, United Kingdom Lifelancer Full time
Job Title: Senior Manager Regulatory Affairs

BeiGene is a rapidly growing company with exciting opportunities for experienced professionals. We are looking for highly motivated, collaborative, and passionate individuals who share our interest in fighting cancer.

Job Summary:

The Senior Manager of GMP/GDP Quality Compliance will support the External Vendor Audit program to ensure regulatory compliance status of BeiGene and vendors. This role will ensure that quality and compliance systems follow applicable global regulatory and health authority requirements.

Key Responsibilities:

  • Execute the external vendor audit program to ensure compliance with existing policies, procedures, standards, regulations, and guidelines.
  • Lead/participate in GMP/GDP compliance audits to identify gaps or risks and develop, issue, and manage audit reports and quality events.
  • Conduct and/or support GMP/GDP BeiGene Internal audit program and maintain and report GMP/GDP compliance audit trends and metrics.
  • Support GMP/GDP Health Authority Inspections and develop and/or maintain SOPs and work instructions pertinent to the External vendor audit program.
  • Other duties as assigned.

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, 5 of which includes management experience; certification as a quality auditor (CQA) is desirable.
  • Knowledge and understanding of current US and EU Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.
  • Understanding of Biopharmaceutical Manufacturing, Analytical Chemistry, and Chemical Manufacturing and business processes.
  • Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
  • Ability to work at a fast pace and multi-task.
  • Working knowledge and experience with 21CFR210 211, ICHQ7, 21CFR600, 21CFR11, Eudralex Vol. 4, Chinese GMP 2010, and other international regulations pertinent to BeiGene's global market.
  • Working knowledge of applicable ISO Standards.

Computer Skills:

  • Strong MS Office Skills: Outlook, Word, Excel, and PowerPoint.

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