Quality Management Lead
2 months ago
The Regeneron GVP Quality Management Lead is a key position that will guide and lead all aspects of quality and compliance within the global pharmacovigilance (PV) system. This role will build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system.
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, including but not limited to: Global Patient Safety (GPS), Medical Affairs, Regulatory, Commercial, etc.
- 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, including Suspected Serious Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending.
- You have skills in taking initiative and working independently across multiple areas.
- You have acted as a PV expert, managed quality and compliance issues related to post-marketing and clinical trial safety.
To be considered, we are looking for individuals with a Bachelor's degree (Master's degree preferred) or equivalent qualification with 8+ years of relevant industry experience. 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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