Global PV QA Leader - Audits, CAPAs & Compliance

R&D Partners; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

R&D Partners in Cambridge, MA, seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide global post-marketing PV system quality oversight, lead audits, and support GVP compliance initiatives.

The ideal candidate has 10+ years in PV QA, deep GVP audit experience, and is adept at CAPAs, deviations, and QMS lifecycle. This role requires strong collaboration across functional teams and readiness for occasional travel and East Coast work hours.

Qualifications

• 10+ years of PV Quality Assurance experience with strong GVP auditing and QA operations.
• Experience leading audits (not just supporting them).
• Strong understanding of PV regulations and GVP requirements.

Responsibilities

• Provide quality oversight of the global post-marketing PV system.
• Develop and execute the global GVP audit program.
• Conduct audits of licensing partners, vendors, affiliates, internal teams, and service providers.
• Evaluate quality events, deviations, root cause analyses, and CAPAs.
• Support risk-based audit strategies and maintain the PV audit universe and schedule.
• Provide audit, CAPA, and supplier data for the Pharmacovigilance System Master File (PSMF).
• Develop and maintain audit processes, tools, and quality metrics.
• Support PV/PMS inspection readiness and inspection management.
• Oversee PV/PMS vendors, including quality agreements, KQIs, vendor qualification, and audits.
• Support GVP QA training and process improvement initiatives.

Skills

PV Quality Assurance

GVP auditing

QA operations

Audits leadership

GVP regulations

Deviation management

CAPAs

PSMF

QMS lifecycle

Pharmaceutical QA experience

Education

Bachelor's degree (minimum)

Advanced degree (Master's/PharmD/PhD)

Tools

Veeva Quality Vault

Job description

R&D Partners in Cambridge, MA, seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide global post-marketing PV system quality oversight, lead audits, and support GVP compliance initiatives.

The ideal candidate has 10+ years in PV QA, deep GVP audit experience, and is adept at CAPAs, deviations, and QMS lifecycle. This role requires strong collaboration across functional teams and readiness for occasional travel and East Coast work hours.