Director, Gps Quality Management Operations

BeOne Medicines

Base: $185,100.00 - $245,100.00 annually; bonus/eq...
8-10 years pv operational experience
4+ years people leadership experience
2+ years leading regulatory inspections
This position has overall responsibility for Global Patient Safety audit and inspection readiness activities, including leading inspection preparation and coordination efforts

Job Summary

  • This position has overall responsibility for Global Patient Safety audit and inspection readiness activities, including leading inspection preparation and coordination efforts.
  • The role requires managing a defined portfolio of Quality Events originating from inspections, audits, and compliance monitoring sources while ensuring the GPS QMS functions effectively.
  • BeOne Medicines offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), Life Insurance, Paid Time Off, and opportunities for discretionary equity awards.

Matching Summary

This position has overall responsibility for Global Patient Safety audit and inspection readiness activities, including leading inspection preparation and coordination efforts.

Salary

Base: $185,100.00 - $245,100.00 annually; Bonus/Equity: Annual bonus plan eligible; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

Skills & Requirements

Must-have

  • 8-10 years PV operational experience
  • 4+ years people leadership experience
  • 2+ years leading regulatory inspections
  • Management of PV quality management systems
  • EU GVP and US global PV requirements knowledge
  • Development of standard operating procedures

Nice-to-have

  • Strong cross-functional partnership skills
  • Experience with continuous improvement initiatives
  • Ability to navigate high-growth environments
  • Public speaking and group facilitation skills
  • Strategic business needs anticipation

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • Advanced Life Sciences Degree preferred
  • Minimum 8 to 10 years PV experience
  • Minimum 4 years team leadership experience
  • Minimum 2 years inspection readiness leadership

Work Rights

Not specified

Tailored Resume

Cover Letter