Senior Manager, Global Pharmacovigilance (PV) Quality Assurance

R&D Partners; Cambridge (MA); Vor Ort; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

PV Quality Assurance

GVP auditing

QA operations

Audits leadership

GVP regulations

Deviation management

CAPAs

PSMF

QMS lifecycle

Pharmaceutical QA experience

Ausbildung

Bachelor's degree (minimum)

Advanced degree (Master's/PharmD/PhD)

Tools

Veeva Quality Vault

Jobbeschreibung

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.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/