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.
• Ensure compliance with applicable regulatory requirements, company procedures, and quality standards.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related scientific discipline.
• Minimum 3+ years of experience within Pharmacovigilance, Drug Safety, Quality Assurance, or GxP-regulated environments.
• Hands-on experience managing CAPAs, Deviations, Non-Conformances, Quality Investigations, or Quality Management Systems.
• Strong knowledge of Pharmacovigilance processes and GxP regulations.
• Experience conducting Root Cause Analysis and writing quality investigation reports.
• Familiarity with audit and inspection support activities.
• Excellent stakeholder management and cross-functional collaboration skills.
• Strong analytical, organizational, and problem-solving abilities.
• Fluent English communication skills, both written and verbal.

Preferred Qualifications

• Experience within a global pharmaceutical, biotechnology, or CRO environment.
• Knowledge of pharmacovigilance quality systems and inspection readiness activities.
• Experience working in global or regional Medical Safety organizations.
• Exposure to electronic Quality Management Systems (eQMS), CAPA management platforms, or compliance tracking tools.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.