CAPA & Quality Operations Specialist (Pharmacovigilance)

We are seeking an experienced CAPA & Quality Operations Specialist to join a global Pharmacovigilance and Medical Safety organization within an FSP model. This role is responsible for leading and coordinating Non-Conformance (NC), Corrective and Preventive Action (CAPA), and Quality Issue management activities, ensuring compliance with global quality standards and maintaining continuous audit and inspection readiness.

The ideal candidate will have a strong background in Pharmacovigilance Operations, Quality Management Systems, CAPA processes, Root Cause Analysis, and GxP compliance, with the ability to collaborate across global cross-functional teams and drive continuous quality improvement initiatives.

Key Responsibilities

CAPA, Quality & Non-Conformance Management

• Act as a key member of the Global LMS Operations CAPA Support Team.
• Own, coordinate, and manage Non-Conformance (NC), Quality Issue (QI), CAPA, and Correction records for LMS activities.
• Lead and support quality investigations, ensuring timely and high-quality documentation.
• Perform and facilitate Root Cause Analysis (RCA) activities and support the development of effective corrective and preventive actions.
• Monitor CAPA and NC records to ensure timely completion, closure, and compliance with quality standards.
• Provide guidance and coaching to stakeholders on CAPA, NC, and Quality Issue management processes.
• Identify trends and recurring issues and collaborate with stakeholders to implement sustainable solutions.
• Generate and present NC/CAPA metrics and quality performance reports for governance meetings and leadership forums.
• Review audit and inspection observations and contribute to continuous process improvement initiatives.

Operational Excellence & Subject Matter Expertise

• Serve as a Subject Matter Expert (SME) for CAPA, Quality Investigations, and Non-Conformance Management within the LMS organization.
• Support process optimization and procedural improvements across global Medical Safety operations.
• Partner with Local Safety Units, Local Safety Officers, Quality teams, and cross-functional stakeholders to ensure consistent global practices.
• Contribute to the development, review, and enhancement of SOPs, work instructions, and quality documentation.

Audit & Inspection Readiness

• Support ongoing audit and inspection preparedness activities across the LMS organization.
• Coordinate CAPA-related responses and documentation requests for audits and regulatory inspections.
• Maintain oversight of quality records and support inspection-related information requests.