Senior Director, Commercial Product Quality External Supply
3 weeks ago
BeiGene 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 commercial product release.
Key Responsibilities:- Lead the Commercial Product Quality team to ensure compliance with regulatory requirements and BeiGene standards.
- Develop and implement quality management processes to ensure product quality.
- Collaborate with cross-functional teams, including Manufacturing, Supply Chain, and Regulatory CMC.
- Manage quality issues and changes at CMOs.
- Ensure that quality processes meet Health Authorities' expectations and continuously improve them.
- Bachelor of Science degree or above in a related scientific discipline/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.
- Excellent interpersonal skills, including communication, negotiations, and facilitations.
- Working knowledge and experience with US, EU, ICH, and/or China GMP regulations.
- Experience in working in a cross-functional and international environment.
- Good presentation skills.
May travel regionally and intercontinentally, estimated up to 30%.
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The recruiter can share more about the specific salary range for a preferred location during the hiring process.
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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 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 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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