Senior Director, Commercial Product Quality External Supply

3 weeks ago


Chaoyang Shi, China BeiGene Full time
Job Title: Senior Director, Commercial Product Quality External Supply

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.
Requirements:
  • 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.
Preferred Qualifications:
  • 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.
Travel:

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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