Global Patient Safety Standards & Training Lead

Regeneron Pharmaceuticals, Inc; Cambourne; Sur place; GBP 113 000 - 143 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join Global Patient Safety Standards & Training.

You will establish and maintain PV procedures aligned with regulations, collaborating with P&P and PONs to ensure audit readiness. Reporting to the Head of GPS Standards & Training, you will develop training curricula, map procedures to regulations, and drive improvements in GPS processes while supporting inspections and CAPA closure.

Qualifications

• Bachelor's degree required; life sciences background is a plus.

Responsabilités

• Ensure PV procedures stay aligned with current regulations and industry standards.
• Collaborate with P&P and LCoE to capture procedural updates and reflect them in training curriculum.
• Validate procedures against safety practices and map documents to regulations and training.
• Develop, implement, and maintain GPS procedures in line with regulations and industry best practices.
• Set risk-based prioritization for procedural updates across GPS framework with PONs and leads.
• Oversee GPS Deviations and CAPA processes including training implications.
• Provide regular metrics on CAPAs, deviations, and training compliance to GPS leadership.
• Represent GPS in audits/inspections and coordinate with cross-functional teams.

Connaissances

PV/Drug Safety

Regulatory affairs

Quality assurance

Project management

Documentation writing

Formation

Bachelor's degree

Description du poste

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join Global Patient Safety Standards & Training.

You will establish and maintain PV procedures aligned with regulations, collaborating with P&P and PONs to ensure audit readiness. Reporting to the Head of GPS Standards & Training, you will develop training curricula, map procedures to regulations, and drive improvements in GPS processes while supporting inspections and CAPA closure.