Validation Remediation Manager

About Abbott

Abbott is a global frontrunner in healthcare, pioneering innovative science to enhance human health. The company remains forward-thinking, anticipating advancements in medical science and technology.

Working at Abbott

At Abbott, employees engage in meaningful work, benefit from career growth and learning opportunities, and enjoy a supportive environment to balance personal and professional life. The company offers:

• Career progression within a global organization supporting your desired career path.
• Recognition as a great workplace internationally and accolades from Fortune as one of the most admired companies worldwide.
• A culture praised for valuing diversity, supporting working mothers, female executives, and scientists.

Role Opportunity

The Validation Remediation Manager leads the transformation, coordination, and execution of validation activities ensuring compliance within regulated operations. This role focuses on sustainable compliance by interpreting regulatory commitments, audit findings, and quality goals to implement a comprehensive lifecycle validation model. The position involves cross-functional collaboration to modernize validation procedures and maintain readiness for inspections.

Key Responsibilities

• Lead validation transformation projects at enterprise or site level to resolve regulatory issues and address business risks by developing a sustainable validation framework.
• Oversee execution of remediation activities across various validation domains including process, cleaning, equipment, utilities, facilities, and computerized systems validation.
• Collaborate with Quality Assurance, Engineering, Manufacturing, IT, Supply Chain, and external experts to align validation efforts with operational and regulatory needs.
• Implement governance frameworks to maintain consistency, compliance, and risk management across teams and locations.
• Apply risk-based evaluations to prioritize validation tasks, deploy interim controls, and justify compliance decisions in regulated settings.
• Prepare and support regulatory inspections and audits ensuring all validation documentation and execution are complete, defensible, and ready for assessment.
• Manage complex validation projects by overseeing timelines, resources, risks, and communications with stakeholders.
• Promote lasting improvements in validation practices, policies, training, and competency development to prevent future compliance issues.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field; advanced degrees are favored.
• Eight to twelve plus years of experience in regulated industries such as pharmaceuticals, biologics, medical devices, or regulated food and nutrition sectors.
• Proven expertise in managing and executing validation lifecycles under regulatory scrutiny.
• In-depth knowledge of MPI and global GMP validation standards.
• Effective leadership of cross-functional teams in high-pressure, complex environments.
• Experience in supporting regulatory inspections, addressing Warning Letters, consent decree remediation, or major recall recoveries.
• Strong skills in computerized system validation (CSV) and data integrity remediation.
• Experience managing external consultants or system integrators.
• Formal project management training or certification, such as PMP, is expected.

Additional Information

This is a fixed-term contract lasting three years based in Pokeno, Waikato District, New Zealand. Abbott encourages candidates seeking diverse career opportunities to apply. The company is an Equal Opportunity Employer committed to fostering a diverse workforce.