CAPA Manager

About the role

The CAPA Manager will lead the Corrective and Preventive Action (CAPA) program, supervising investigators and analysts while coordinating cross‑functional teams to ensure product quality and regulatory compliance.

Key responsibilities

• Directly supervise a team of CAPA Investigators and analysts.
• Lead extended, multi‑functional teams in non‑conformance investigations and corrective actions.
• Develop and deliver training material for the CAPA program.
• Establish and drive strategies to meet site and division quality and compliance goals.
• Review CAPA investigations for completeness, timeliness, and regulatory adherence.
• Manage resolution confirmation and work with event owners to ensure quality and timeliness.
• Verify product safety and efficacy assessments and elevate safety risks.
• Execute the Executive Management Review Program and compile relevant metrics.
• Serve as liaison to Corporate Quality for global exception reporting and the Quality Systems Data Warehouse.
• Authorize changes to CAPA Management Systems and act as primary contact during regulatory inspections.

Required profile

• Proven experience supervising CAPA investigators or similar quality teams.
• Strong knowledge of regulatory requirements and quality system policies.
• Ability to develop training programs and drive compliance initiatives.
• Excellent analytical and problem‑solving skills for root‑cause investigations.
• Effective communication with cross‑functional stakeholders and senior management.

Required skills

What we offer

• Career development within a global healthcare leader.
• Recognition as a top employer for diversity and inclusion.
• Opportunities to work on breakthrough science that improves health.