Senior Director, Commercial Product Quality External Supply

2 months ago

Chaoyang Shi, China BeiGene Full time

Job Summary:

The Senior Director, Commercial Product Quality External Supply will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labeled, stored, and transported in a controlled manner that meets regulatory expectations and applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality standards.

Key Responsibilities:

  • Lead a team of quality professionals to ensure product quality from CMOs and collaborate with Distribution and Regional Quality teams to oversee commercial product on the end-to-end supply chain.
  • Develop and implement quality management processes to ensure compliance with regulatory requirements and BeiGene standards.
  • Manage quality issues and changes at CMOs, including batch record review, deviation handling, and CAPA implementation.
  • Perform batch dispositions, prepare batch-related documents, and manage temperature excursions from storage and transportation.
  • Ensure quality processes meet Health Authority expectations and continuously improve them by timely capturing related regulation changes.
  • Advise and support Quality Agreement content, implementation, and updates.
  • Obtain quality performance information at CMOs and drive continuous improvement, providing performance metrics information to CMO vendor management teams and escalating any quality or compliance issues to senior management as needed.
  • Closely collaborate with CMO Vendor Management teams on vendor performance monitoring and periodic review, supporting audits as required.
  • Work cross-functionally and collaboratively with BeiGene teams, including Manufacturing, Supply Chain, Regulatory CMC, and other Quality teams.
  • Provide quality support on product commercial supply, including timely batch release.
  • Support Good Clinical Practice (GCP) inspections in IMP manufacturing perspective.
  • Execute product recalls from commercial supply chains when needed.
  • Perform other tasks as assigned in accordance with SOPs, regulatory agencies, and GxP guidelines.

Supervisory Responsibilities:

  • Responsible for management, development, and coordination of a medium-sized team of direct staff based globally.
  • Accountable for financial control and management of related budgets, including headcount-related and travel expenses.
  • Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and ongoing professional development to maintain proficiency.
  • Build a talent pipeline by inspiring and encouraging team members and creating a great place to work for their personal development and career success.

Requirements:

  • Bachelor of Science degree or above in a related scientific discipline/technical field, such as Pharmacy, Biology, Chemistry, or Engineering.
  • Minimum 12 years of pharmaceutical or biotechnology industry experience.
  • In-depth GMP experience in a quality and manufacturing function.
  • Prior experience in commercial GMP batch release.
  • In-depth knowledge of Quality principles, concepts, industry practices, and standards.
  • Working knowledge and experience with US, EU, ICH, and/or China GMP regulations as well as international regulations.
  • Excellent interpersonal skills, including communication, negotiation, and facilitation.
  • Experience in working in a cross-functional and international environment.
  • Good presentation skills.
  • Ability to work independently.
  • Spoken/Written fluency in English required.

Computer Skills:

  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

  • May travel regionally and intercontinentally, estimated up to 30%.

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