About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Validation Remediation Manager is responsible for leading the transformation, integration, and execution of validation activities across regulated operations.

This role drives sustainable compliance by translating regulatory commitments, audit observations, and enterprise quality objectives into an integrated, lifecycle-based validation model. The position provides cross-functional leadership to modernize validation practices while ensuring inspection-ready execution.

What You'll Do:

• Validation Transformation & Strategy: Lead enterprise or site-level validation transformation initiatives to address regulatory findings and business risks while establishing a sustainable future-state validation framework.
• Remediation Execution & Integration: Drive execution of validation remediation activities across process validation, cleaning validation, equipment and utility qualification, facilities qualification, and computerized system validation (CSV).
• Cross-Functional Leadership: Partner with Quality Assurance, Engineering, Manufacturing, IT, Supply Chain, and external consultants to align validation execution with operational and regulatory priorities.
• Governance & Oversight: Establish and oversee validation governance models, ensuring consistency, compliance, and effective risk management across functions and sites.
• Risk-Based Decision Making: Evaluation Validation deliverables and procedures to prioritize activities, implement interim controls, and justify compliance decisions in regulated environments.
• Inspection Readiness: Support regulatory inspections and audits by ensuring validation documentation, rationales, and execution are defensible, complete, and inspection-ready.
• Project & Program Management: Manage timelines, milestones, resources, and risks for complex validation initiatives; provide clear status reporting and escalation.
• Sustainability & Capability Building: Drive long-term improvements to validation standards, SOPs, templates, training, and competency models to prevent recurrence of compliance gaps.

Requirements:

• Bachelor's degree in Engineering, Science, or a related technical discipline (advanced degree preferred).
• 8–12+ years of experience in a regulated industry (pharmaceuticals, biologics, medical devices, or regulated food/nutrition).
• Demonstrated expertise in validation lifecycle management and execution under regulatory scrutiny.
• Strong knowledge of MPI and global GMP validation requirements.
• Proven ability to lead cross-functional teams in complex, high-pressure environments.
• Experience supporting inspections, Warning Letter or consent decree remediation, or major recall recovery efforts.
• Strong background in CSV and data integrity remediation.
• Experience leading external consultants or system integrators.
• Formal project management training or certification (e.g., PMP).

This is a 3-years fixed term contract opportunity.

Location:

This position is based in Waikato District > Pokeno.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.