Senior Director, Commercial Product Quality External Supply
4 weeks ago
BeiGene is a global biotechnology company that is committed to developing innovative cancer therapies. We are seeking a highly experienced and motivated Senior Director, Commercial Product Quality External Supply to join our team.
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. This role will have global responsibility and accountability for commercial product quality for global supply.
Key Responsibilities:
- Lead a team of quality professionals to ensure the product quality from CMOs
- Closely work with Distribution and Regional Quality teams to oversee commercial product on the end-to-end supply chain
- Manage quality issues and changes at CMOs
- Ensure that quality processes meet Health Authorities' 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
- Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required
- Will work cross-functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC, and other Quality teams like QPs in EU
- Provide quality support on product commercial supply e.g. timely batch release
- Support GCP inspections in IMP manufacturing perspective
- Execute product recalls from commercial supply chain when needed
Requirements:
- Bachelor of Science degree or above, in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry, or Engineering
- Minimum 12 years 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, negotiations, facilitations
- Experience in working in a cross-functional and international environment
- Good presentation skills
- Ability to work independently
- Spoken/Written fluency in English required
Travel:
- May travel regionally and intercontinentally estimated up to 30%
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Chaoyang Shi, China BeiGene Full timeGrowth Opportunities at BeiGene BeiGene, a rapidly expanding pharmaceutical company, offers experienced professionals exciting opportunities for growth and development. When selecting candidates, we look for motivated, collaborative, and results-driven individuals who share our passion for fighting cancer. Job Summary: The Senior Director, Commercial...
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Chaoyang Shi, China BeiGene Full timeBeiGene is seeking a Senior Director, Commercial Product Quality External Supply, who will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality...
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Chaoyang Shi, China BeiGene Full timeBeiGene is committed to delivering high-quality products that meet the needs of patients around the world. As a key member of our team, you will play a critical role in ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labelled, stored, and transported in accordance with regulatory expectations and...
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