Senior Manager, Quality Assurance

vor 2 Monaten

Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

Job Summary:

The Senior Manager of GMP/GDP Quality Compliance supports the BeiGene External Vendor Audit program to ensure the regulatory compliance status of BeiGene and vendors. This role is responsible for ensuring 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 any associated quality events.
  • Conduct and/or support GMP/GDP BeiGene Internal audit program to 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.

Supervisory Responsibilities:

  • This position may include managing globally located staff; coaching and mentoring of junior staff with training / orientation / qualification and development plan when required.

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 the 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.
  • Knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.
  • 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 as well as 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.

Travel:

  • May require up to 50% travel.

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