Senior GCP Audit & Risk Oversight Manager

Pfizer, S.A. de C.V; Dublin; Hybrid; EUR 110,000 - 180,000; Full time

Job summary

Pfizer is seeking a Senior Manager – GCP Auditor to plan, lead and conduct independent GCP audits and risk oversight. This role interfaces with business representatives to recommend oversight approaches for risk mitigation.

The position requires extensive GCP experience, strong regulatory knowledge, and proven leadership to drive audits across complex clinical development programs. Based in Ireland, it offers broad impact and collaborative global opportunities.

Qualifications

• Bachelor's degree in Biology, Chemistry, Nursing, Medical Technology, Pharmacy or health.
• Ten+ years of relevant GCP international operational experience in clinical development.
• Five years' experience in GCP quality-related compliance.
• Strong knowledge of ICH GCP and global/local regulations.
• Experience in GCP risk assessment or analysis is preferred.
• Ability to assess systems and processes and identify gaps and risks.
• Strong analytical and communication skills for presenting findings.

Responsibilities

• Plan, lead and conduct GCP independent audits and risk oversight activities.
• Provide inputs for audit targets and develop customized audit plans.
• Communicate audit findings and practical recommendations to management.
• Conduct or support other oversight activities and update procedures as needed.
• Manage multiple projects and maintain alignment with corporate audit.

Skills

GCP auditing

GCP quality compliance

ICH GCP knowledge

Regulatory knowledge

Data analytics

Risk assessment

Project management

Leadership

Communication

Negotiation

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Pfizer is seeking a Senior Manager – GCP Auditor to plan, lead and conduct independent GCP audits and risk oversight. This role interfaces with business representatives to recommend oversight approaches for risk mitigation.

The position requires extensive GCP experience, strong regulatory knowledge, and proven leadership to drive audits across complex clinical development programs. Based in Ireland, it offers broad impact and collaborative global opportunities.