Validation Remediation Manager (Contractor)

JOB DESCRIPTION:

The Opportunity

Abbott has entered into an agreement to purchase Synlait’s North Island assets in New Zealand, including the Pōkeno manufacturing facility. Acquiring this facility supports Abbott’s anticipated growth in the Pacific Asia region across our adult and pediatric nutrition products. The pending close of the agreement is April 1, 2026.

This position works out of our Pokeno Site location in the Nutrition Division

As the Validation Transformation Lead ,QA

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.

Required Qualifications

• 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 FDA, EMA, and global GMP validation requirements.
• Proven ability to lead cross-functional teams in complex, high-pressure environments.

Preferred Qualifications

• Experience supporting FDA 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).

Core Competencies

• Regulatory and compliance acumen
• Validation lifecycle and systems thinking
• Change and transformation leadership
• Program and project management
• Executive communication and influence
• Risk-based decision making

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Divisional Information

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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