CAPA Manager

About Abbott

Abbott is a leading global healthcare company dedicated to pioneering innovative science that enhances people's health. The organization continuously anticipates advancements in medical science and technology to stay ahead.

Working at Abbott

Abbott offers meaningful work opportunities where employees can grow professionally, learn continuously, and maintain a healthy work-life balance. Benefits include career development within an international environment, recognition as a top employer globally and for diversity, and support for working mothers and female leaders.

Role Overview and Responsibilities

• Lead and directly supervise a team of CAPA Investigators and analysts, as well as coordinate with cross-functional members across multiple sites for critical product line investigations affecting site success and financial outcomes.
• Develop and deliver training materials for the CAPA program, ensuring strategies enhance performance and compliance with regulatory standards.
• Formulate and implement strategies to meet site and division quality and compliance targets related to CAPA investigations and metrics.
• Establish and maintain Quality System policies and procedures to ensure regulatory compliance.
• Review and validate CAPA investigations for thoroughness, completeness, and timeliness conducted by qualified staff.
• Oversee the CAPA resolution confirmation process, collaborating with event owners and divisional leaders to guarantee quality and timely compliance.
• Confirm product safety and efficacy evaluations are completed and escalate safety or patient-related issues for risk assessment.
• Ensure execution of Executive Management Review Programs, including metrics compilation and cross-functional trend analysis to identify and address adverse patterns.
• Act as division liaison to Corporate Quality teams for maintaining global Exception reporting systems, CAPA, and Quality Systems Data Warehouse.
• Authorize modifications to CAPA Management Systems and serve as primary contact during regulatory inspections and corporate audits.
• Collaborate with multiple functional areas such as operations, R&D, marketing, supply chain, quality, and regulatory affairs.
• May require occasional work outside standard hours for essential trainings, meetings, and events, including evenings or weekends.

Qualifications

• Bachelor's degree in engineering, science, quality, or a related field, or equivalent experience.
• At least eight years of experience in Quality, Manufacturing, or CAPA management within regulated manufacturing environments.
• Comprehensive knowledge of CAPA systems, root cause analysis techniques, and risk-based management approaches.
• Strong judgment, problem-solving capabilities, and decision-making skills.
• Effective communicator with excellent written and verbal skills and strong interpersonal abilities.
• Organized and proficient with technology.
• Deep understanding of relevant technical and regulatory requirements locally.
• Demonstrated project management and execution proficiency.

Location

This position is located in Pokeno, Waikato District, New Zealand.

Equal Opportunity Employer

Abbott is committed to diversity and inclusion and is an Equal Opportunity Employer offering various career opportunities for growth and development.