Senior Global PV QA & Audit Leader

R Dpartners; Town of Cambridge; On-site; AUD 215,000 - 301,000; Full time

Job summary

R&D Partners seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality oversight of global post-marketing PV systems and lead the GVP audit program. You will audit licensing partners, vendors, affiliates, and internal teams, evaluate quality events and CAPAs, and support inspection readiness.

Strong PV QA, GVP auditing, and QMS lifecycle experience are essential. Ideal candidates have 10+ years in PV QA, Bachelor's degree, and proven leadership in audits.

Qualifications

• 10+ years in PV QA with strong GVP auditing experience.
• Experience leading audits, not just supporting.
• Bachelor's degree required; advanced degree preferred.

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 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 QA

GVP auditing

Audit leadership

QA operations

Regulatory compliance

Deviation management

CAPA process

QMS lifecycle

PSMF familiarity

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Tools

Veeva Quality Vault

Job description

Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities.

R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality oversight of global post-marketing PV systems. This role focuses on auditing, QA operations, and supporting GVP compliance activities. The ideal candidate will have extensive experience in PV Quality Assurance, GVP auditing, and Quality Management Systems (QMS).

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Provide quality oversight of the company’s 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.

Key Skills and Requirements:

Must-Have:

• 10+ years of experience in PV Quality Assurance, with strong GVP auditing and QA operations expertise.
• Proven experience leading audits (not just supporting them).
• Strong understanding of PV regulations and GVP requirements.
• Experience with deviation management, CAPAs, quality events, change controls, and QMS lifecycle.
• Familiarity with the Pharmacovigilance System Master File (PSMF).
• Pharmaceutical industry experience in a quality/QA function.
• Bachelor’s degree (minimum).

Nice-to-Have (Preferred):

• Advanced degree (Master’s, PharmD, or PhD in Pharmacy).
• Experience with digital QMS tools like Veeva Quality Vault.
• Familiarity with PV/PMS vendors, licensing partners, and global GVP regulations.
• Experience supporting Health Authority inspections.

Ideal Candidate Profile:

We are looking for a seasoned PV professional with a strong focus on quality and auditing rather than compliance. The candidate should be self-motivated, proactive, and comfortable handling complex quality issues. Strong communication and cross-functional collaboration skills are essential.

Additional Information:

• Work Hours: Must be able to work East Coast hours.
• Travel: Occasional travel required for audits.

For more information, please contact William Tyler.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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