Senior Director, Commercial Product Quality External Supply
6 days ago
Growth 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 Product Quality External Supply will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) meet regulatory expectations and applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality standards. This role has global responsibility and accountability for commercial product quality for global supply.
Key Responsibilities:
- Lead a team of quality professionals to ensure product quality from CMOs.
- Collaborate with Distribution and Regional Quality teams to oversee commercial product supply chain.
- Develop and implement quality management processes to ensure compliance with regulatory requirements and BeiGene standards.
- Manage quality issues and changes at CMOs.
- Perform batch record reviews, deviation handling, and CAPA implementation.
- Ensure quality processes meet Health Authorities' expectations and continuously improve them.
- Advise and support Quality Agreement content, implementation, and updates.
- Obtain quality performance information at CMOs and drive continuous improvement.
- Collaborate with CMO Vendor Management team on vendor performance monitoring and periodic review.
- Provide quality support on product commercial supply and execute product recalls when needed.
- Perform other tasks as assigned.
Supervisory Responsibilities:
- Manage, develop, and coordinate a team of quality professionals globally.
- Ensure team members have adequate product and process knowledge for GMP/GDP obligations.
- Build a talent pipeline by inspiring and encouraging team members.
Requirements:
- Bachelor's degree or above in a related scientific discipline or technical field.
- 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.
- Knowledge of Quality principles, concepts, industry practices, and standards.
- Working knowledge and experience with US, EU, ICH, and/or China GMP regulations.
- Excellent interpersonal skills, including communication, negotiations, and facilitations.
- Experience in working in a cross-functional and international environment.
- Good presentation skills.
- Ability to work independently.
- Fluency in English required.
Travel:
- May travel regionally and intercontinentally estimated up to 30%.
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Chaoyang Shi, China BeiGene Full timeBeiGene 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...
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Chaoyang Shi, China BeiGene Full timeJob Title: Senior Director, Commercial Product Quality External SupplyBeiGene is seeking a highly experienced Senior Director to lead our Commercial Product Quality team, responsible for ensuring the quality of commercial products at Contract Manufacturing Organizations (CMOs). The ideal candidate will have a strong background in GMP, quality management, and...
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Chaoyang Shi, China BeiGene Full timeJob SummaryWe are seeking a highly experienced Senior Director, Commercial Product Quality External Supply to join our team at BeiGene. As a key member of our Commercial Product Quality team, you will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labelled, stored, and transported...
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Chaoyang Shi, China BeiGene Full timeJob SummaryBeiGene is seeking a highly experienced Senior Director, Commercial Product Quality External Supply to join our team. As a key member of our Commercial Product Quality team, you will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labeled, stored, and transported in a...
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Chaoyang Shi, China BeiGene Full timeJob 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...
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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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