CAPA Manager

Abbott Laboratories; New Zealand; On-site; NZD 150,000 - 190,000; Full time

Job summary

Abbott Laboratories in New Zealand seeks a CAPA leader to oversee investigations and compliance across multiple product lines at the Pokeno plant. You will supervise CAPA investigators, drive root-cause analysis, and ensure timely, thorough documentation and regulatory alignment.

You will develop strategies to achieve quality goals, manage risk, and liaise with Corporate Quality for global reporting. Travel and additional training may be required to support inspections and audits.

Qualifications

• Bachelor’s degree in engineering, science, quality, or related discipline (or equivalent experience).
• Minimum eight years of experience in quality, manufacturing, and/or CAPA management within regulated manufacturing environments.
• Strong working knowledge of CAPA systems, root-cause analysis, and risk-based management.
• Demonstrated judgment, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills with strong interpersonal and consulting ability.

Responsibilities

• Lead CAPA investigations with cross-functional teams to identify root causes and implement corrective actions.
• Develop strategies to meet site and division quality and compliance goals related to CAPA investigations and metrics.
• Review CAPA investigations to ensure thorough, complete, and timely documentation.
• Manage resolution confirmation and coordinate with event owners and management to ensure CAPA quality and regulatory compliance.
• Create training materials for CAPA staff to enhance performance and compliance with regulatory requirements.
• Verify product safety and efficacy and elevate safety/patient issues for risk evaluation.
• Compile and review metrics for Executive Management Review to identify adverse trends and drivers.
• Act as liaison to Corporate Quality for global exception reporting, CAPA, and QSDW.

Skills

CAPA management

Root-cause analysis

Risk-based decision making

Project management

Communication skills

Education

Bachelor’s degree in engineering, science, quality, or related discipline

Tools

CAPA software

Job description

Overview

Abbott is a global healthcare leader committed to improving people’s health. This role involves leading the CAPA investigation and compliance process within the Pokeno plant, ensuring quality and regulatory compliance across multiple product lines.

Responsibilities

• Supervise a team of CAPA investigators and analysts, and lead an extended, cross‑functional team in the performance of non‑conformance investigations and corrective actions.
• Develop and drive strategies to achieve site and division quality and compliance goals related to CAPA investigations and metrics program.
• Review CAPA investigations to ensure that documents are thorough, complete, and timely.
• Manage the resolution confirmation process and work with event owners and division management to ensure CAPA quality, timeliness and other compliance parameters.
• Create training materials and programs for CAPA staff to maximize performance and compliance with regulatory requirements.
• Verify product safety and efficacy, and elevate safety/patient issues for risk evaluation.
• Execute the Executive Management Review program, compiling and reviewing relevant metrics to identify adverse trends and drivers.
• Serve as liaison to the Corporate Quality organization for global exception reporting, CAPA, and the Quality Systems Data Warehouse (QSDW).
• Authorize changes to CAPA management systems and act as the primary CAPA system contact during regulatory inspections and corporate audits.
• Support interactions across operations, R&D, marketing, supply chain, quality, and regulatory.
• Participate in essential training, meetings, and events, which may occur outside ordinary hours, evenings or weekends.

Qualifications

• Bachelor’s degree in engineering, science, quality, or related discipline (or equivalent experience).
• Minimum eight (8) years of experience in quality, manufacturing, and/or CAPA management within regulated manufacturing environments.
• Strong working knowledge of CAPA systems, root‑cause analysis, and risk‑based management.
• Demonstrated judgment, problem‑solving, and decision‑making skills.
• Effective written and verbal communication skills with strong interpersonal and consulting ability.
• Well‑organized and tech‑savvy.
• Excellent technical and regulatory local knowledge as it relates to the role.
• Proven project management and execution skills.

Location

This position is based in Waikato District – Pokeno Plant, New Zealand.

Additional Information

• Standard shift; travel requirements not specified.
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day).

Equal Opportunity Employer

Abbott is an Equal Opportunity Employer, committed to employee diversity.