Senior Manager, Global Development Quality Management (GVP)

The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues.

In this role, a typical day might include the following:

• Responsible for leading 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 can make decisions on complex issues under minimal guidance that have a significant impact on business operations related to PV.


• You are self-motivated with the ability to work effectively and provide mentorship to others in a dynamic environment with ambiguity.


• You bring expertise of GVP and are a sought-out resource to evaluate novel problems and develop innovative solutions for critical organization-wide issues.


• 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 Bachelors' degree (Master's degree preferred) or equivalent qualification with 8+ years of relevant industry experience.