Global PV Standards & Training Associate Director

BioSpace; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director for the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures compliant with global regulations and collaborate with P&P, LCoE, and SMEs to align training curricula.

The role requires 7+ years in PV/QA, deep PV process design experience, and the ability to drive audits and inspections while leading cross-functional initiatives. Onsite work is required in multiple locations with travel.

Qualifications

• Bachelor's degree required; life sciences is a plus.
• 7+ years in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance.
• Thorough understanding of PV regulations and PV QMS.
• Extensive experience managing procedural updates.
• Experience in PV process design and optimization.
• Track record of successful project management related to document management.

Responsibilities

• Ensure PV intelligence updates are reflected in GPS procedures and training readiness.
• Liaise with P&P and LCoE for procedural updates and curriculum alignment.
• As SME, validate procedures are fit for purpose against safety practices and regulations.
• Develop, implement, and maintain GPS procedures aligned with regulations and industry best practices.
• Lead prioritization and sequencing of procedural updates across the GPS framework with PONs.
• Ensure correct procedural documents are assigned to the training curriculum.
• Oversee GPS Planned Process Deviations and GDQ approval criteria.
• Coordinate with P&P to align PPD dates with procedure projects and adjust timelines.
• Escalate and resolve non-compliance through senior management and stakeholders.
• Manage content of GPS procedures with Process Owners; ensure CAPA closure and training timing.
• Provide metrics on CAPAs, deviations, and training compliance to GPS leadership.
• Lead initiatives to improve GPS process effectiveness and performance metrics.
• Regularly liaise with Corporate and Clinical QA on GPS impacts or GXP activities.
• Represent GPS Standards & Training in audits and inspections.
• Backup GPS Standards & Training liaison to LCoE.

Skills

PV regulations

PV process design

Project management

Technical writing

Audits & inspections

Cross-functional collaboration

Education

Bachelor's degree

Job description

Regeneron is seeking an Associate Director for the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures compliant with global regulations and collaborate with P&P, LCoE, and SMEs to align training curricula.

The role requires 7+ years in PV/QA, deep PV process design experience, and the ability to drive audits and inspections while leading cross-functional initiatives. Onsite work is required in multiple locations with travel.