Validation Remediation Manager (3 Years Contract)

About Abbott

Abbott is a leading global healthcare organization dedicated to pioneering scientific advancements that enhance people's health. The company embraces future innovations and changes in medical science and technology.

Work Environment

Joining Abbott means engaging in meaningful work with opportunities for personal growth and learning. Employees have access to career development within a global firm recognized worldwide as an exceptional place to work. Abbott has earned accolades for being among the most admired companies globally and is known for championing diversity, supporting working mothers, and promoting female leadership and scientific excellence.

Role Overview

The Validation Remediation Manager will spearhead the transformation, integration, and management of validation activities across regulated operations. This position focuses on ensuring lasting compliance by translating regulatory requirements, audit findings, and quality goals into a cohesive, lifecycle-driven validation approach. Cross-functional leadership is essential to modernize validation processes while maintaining readiness for regulatory inspections.

Key Responsibilities

• Lead validation transformation initiatives at the enterprise or site level to address regulatory and business risks and establish a robust future-state validation model.
• Oversee execution of remediation activities including process validation, cleaning validation, equipment and utility qualifications, facilities qualification, and computerized system validation.
• Collaborate with Quality Assurance, Engineering, Manufacturing, IT, Supply Chain, and external consultants to align validation efforts with operational and regulatory priorities.
• Develop and manage governance frameworks to ensure consistent compliance and effective risk management across teams and locations.
• Apply risk-based decision making to evaluate validation deliverables, prioritize activities, and establish interim controls in regulated contexts.
• Prepare and support regulatory inspections and audits by maintaining accurate, thorough, and defensible validation documentation and execution.
• Manage complex validation projects including timelines, resources, milestones, risks, and provide transparent status updates with escalation as needed.
• Drive continual improvements to validation standards, policies, training, and competency frameworks to eliminate repeat compliance issues.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical field; advanced degrees preferred.
• 8 to 12+ years of experience within regulated sectors such as pharmaceuticals, biologics, medical devices, or regulated food/nutrition industries.
• Extensive expertise in managing and executing validation lifecycles compliant with stringent regulatory environments.
• In-depth knowledge of the Ministry for Primary Industries (MPI) and worldwide Good Manufacturing Practice (GMP) validation standards.
• Proven leadership in cross-functional teams handling complex validation challenges under pressure.
• Experience in supporting inspections and remediation related to Warning Letters, consent decrees, or major product recalls.
• Strong background in Computerized System Validation (CSV) and addressing issues around data integrity.
• Skilled in managing relationships with external consultants and system integrators.
• Formal project management training or certification such as PMP is desirable.

Additional Information

This is a fixed-term contract lasting three years. The position is located in Pokeno, within the Waikato District of New Zealand.

Abbott fosters a culture of equal opportunity and values diversity across its workforce. Candidates are welcomed to pursue their career goals with Abbott, where a supportive environment enables living one’s best life.