Director, Product Quality Lead

BeiGene

Base: $172,000.00 - $232,000.00 annually; bonus/eq...
Not specified (potentially hybrid or onsite)
8+ years quality sciences experience
Regulatory compliance fda ema ich q9
Quality risk management frameworks
BeiGene is seeking a Director, Product Quality Lead to enhance global quality initiatives within the Quality Sciences and Knowledge Management organization. The ideal candidate will have a strong background in quality sciences, regulatory compliance, and leadership, particularly in the pharmaceutical or biotechnology sectors

Job Summary

  • The Product Quality Lead will play a critical role in advancing global quality initiatives and ensuring the highest standards of product quality within a rapidly growing pharmaceutical organization.
  • This position requires extensive experience in leading quality investigations, implementing new technologies, and managing complex regulatory submissions for late-phase clinical or commercial programs.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and opportunities for discretionary equity awards to all employees.

Matching Summary

Match Score: 85

BeiGene is seeking a Director, Product Quality Lead to enhance global quality initiatives within the Quality Sciences and Knowledge Management organization. The ideal candidate will have a strong background in quality sciences, regulatory compliance, and leadership, particularly in the pharmaceutical or biotechnology sectors.

Salary

Base: $172,000.00 - $232,000.00 annually; Bonus/Equity: Annual bonus plan eligible with discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • 8+ years quality sciences experience
  • Regulatory compliance FDA EMA ICH Q9
  • Quality risk management frameworks
  • CMC strategy and lifecycle management
  • Cross-functional team leadership

Nice-to-have

  • Mentoring and developing team members
  • Statistical modeling software proficiency
  • Lean Six Sigma methodology expertise
  • Global training program development
  • Emerging scientific trend analysis

Key Requirements

  • Bachelor's degree required; Master's preferred
  • 5+ years direct managerial experience
  • Experience in regulated pharmaceutical industry
  • Expertise in ICH Q9 and FDA/EMA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter