Senior Manager, Global Development Quality Management

6 days ago


Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Manager, Global Development Quality Management to lead our global pharmacovigilance (PV) system. As a key member of our team, you will be responsible for building strategic partnerships and directing risk-based quality management activities with key partners.

Key Responsibilities
  • Lead GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML
  • Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the Regeneron global PV system
  • Participate in process improvement activities, lead projects in support of quality objectives, and support inspection readiness activities
  • Act as a primary liaison to GPS to advise on any quality issues and ensure compliance
  • Provide day-to-day quality and compliance support to cross-functional team members
Requirements
  • Bachelor's degree (Master's degree preferred) or equivalent qualification
  • 8+ years of relevant industry experience
  • Expertise in GVP and ability to evaluate novel problems and develop innovative solutions
  • Ability to work effectively and provide mentorship to others in a dynamic environment
What We Offer

We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.



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