Global Pharmacovigilance Quality Manager

Alkermes; Boston (MA); On-site; USD 135,000 - 149,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Alkermes in Boston seeks a Manager, Clinical Quality Assurance (Pharmacovigilance Quality) to lead the global Pharmacovigilance Quality System and REMS programs, ensuring compliance with GVP and regulatory expectations across development and post-marketing activities.

You will drive risk-based audits, vendor oversight, quality metrics, and inspection readiness, partnering with Drug Safety, Regulatory Affairs, and IT to enable safe, compliant medicines for patients worldwide.

Qualifications

• 8+ years of pharmaceutical, biotechnology, or regulatory experience.
• Direct experience leading global Pharmacovigilance Quality programs.
• Experience with FDA and EMA inspections.

Responsibilities

• Lead the development, implementation, and continuous improvement of the global Pharmacovigilance Quality Management System.
• Provide independent quality oversight of pharmacovigilance processes across development and commercial products.
• Support health authority inspections, mock inspections, and inspection responses.

Skills

Quality oversight

Auditing

Vendor oversight

Regulatory compliance

Education

Bachelor's Degree

Tools

Argus Safety

ArisGlobal LifeSphere

Oracle Safety

Veeva Quality

TrackWise

ComplianceWire

Job description

Alkermes in Boston seeks a Manager, Clinical Quality Assurance (Pharmacovigilance Quality) to lead the global Pharmacovigilance Quality System and REMS programs, ensuring compliance with GVP and regulatory expectations across development and post-marketing activities.

You will drive risk-based audits, vendor oversight, quality metrics, and inspection readiness, partnering with Drug Safety, Regulatory Affairs, and IT to enable safe, compliant medicines for patients worldwide.