Global PV QA Senior Manager – Inspection Ready

Planet Pharma; Cambridge (MA); On-site; USD 117,000 - 131,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Planet Pharma seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to oversee the global post-marketing PV system, ensuring GVP compliance, PMS execution, audits, and inspection readiness. The role reports to the Director, Global PV Quality Assurance and collaborates with cross-functional teams in EA.

This on-site, contract position is based in Cambridge, MA with an hourly pay range of $85–$95 based on experience.

Qualifications

• University degree in life sciences or equivalent.
• Experience in pharmaceutical quality/compliance.
• Experience with GVP audits and regulatory inspections.
• Understanding of FDA PV requirements and ICH.
• Strong communication and cross-functional collaboration.

Responsibilities

• Lead PV QA audits and inspections readiness for the PV system.
• Oversight of global PV quality processes, CAPA management, and risk-based quality assurance.
• Collaborate with cross-functional teams (EA) to ensure GVP compliance and training.
• Develop and maintain PV QA metrics, dashboards, and GVP training plans.
• Support vendor qualification, audits, and PV system master file data management.

Skills

Quality Assurance

GVP Audits

Regulatory Compliance

Audit Experience

Communication Skills

Problem Solving

Education

University degree in life sciences

Job description

Planet Pharma seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to oversee the global post-marketing PV system, ensuring GVP compliance, PMS execution, audits, and inspection readiness. The role reports to the Director, Global PV Quality Assurance and collaborates with cross-functional teams in EA.

This on-site, contract position is based in Cambridge, MA with an hourly pay range of $85–$95 based on experience.