Director Site Quality Assurance

Abbott • Minneapolis, MN

2d • $163,000 - $326,000 • Onsite

About The Position

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. Abbott Nutrition is seeking a dynamic QA leader for the role of Director, Site Quality Assurance at our New Zealand site. We are also open for a 2-3 year international expat assignment at our New Zealand site. This position is based at our Pokeno facility within Abbott Nutrition and will play a critical role in driving quality excellence and supporting the successful integration of Synlait into Abbott’s global operations. The Director of Quality Assurance (QA) is responsible for leading and coordinating all Quality Assurance activities at the Abbott Nutrition New Zealand site. This role ensures the implementation and continuous improvement of comprehensive QA systems, processes, and programs aligned with the company’s quality standards to consistently deliver high-quality products and exceed customer expectations. The Director will define and execute strategies that optimize compliance, enhance organizational efficiency, and manage costs through the adoption of new technologies, evaluation of current practices, knowledge sharing, and the application of Business Excellence tools. In partnership with the Site Director, this position holds accountability for plant compliance and serves as a key advisor to Division leadership on critical matters, including product quality, safety, and regulatory issues. Additionally, the Director plays a pivotal role in supporting the timely and compliant introduction of new products to market. This position requires close collaboration and strategic alignment with site leadership teams and peers across Global Manufacturing, Materials Management, Engineering, R&D, Commercial Operations, Regulatory Affairs, and Legal. The role also involves direct engagement with external business partners and regulatory authorities to uphold quality and compliance standards.

Requirements

• Bachelor’s degree in Business Administrations, Life Science, Engineering, Industrial Technology or related field.
• 7+ years in Quality or compliance discipline in an FDA regulated Industry
• 7+ years Supervisory/Management experience

Responsibilities

• Integration Leadership: Manage the end-to-end integration of Synlait, ensuring operational, cultural, and strategic alignment.
• Directs the Plant Quality Assurance Operations Organization to ensure positive compliance outcomes at the site.
• Develops the site quality strategy to achieve business objectives at the plant level while ensuring operations is in compliance with global regulatory requirements, making key decisions on product quality and regulatory conformance issues.
• Directs and implements programs at the site to comply with all regulatory requirements to ensure products and services meet customer expectations.
• Supports the resolution of product quality issue resolutions with Division Quality Assurance, Medical, Regulatory Affairs, Legal, Operations, Materials Management, Purchasing and Engineering.
• Assure line of communication with Senior Leaders on critical quality issues that may result in potential business interruption.
• Provide oversight to disposition of high risk product non-conformance situations, assure adequate investigation and corrective actions are in place to prevent future occurrences.
• - Assure staffing and leadership continuity through talent management succession planning and developmental moves. Create a diverse organization and encourage diversity within the organization.
• In conjunction with Division Quality, monitor consumer complaint trends, identify, communicate and address adverse trends that may impact future business. Ensure corrective and preventative actions are taken to prevent recurrence.
• - Assure successful launch of new and revised products by incorporating the appropriate quality assurance programs/systems into plant operations.
• - Directly responsible with interface with outside regulators ( FDA, Ministries of Health, Notified Bodies) and other government regulatory bodies. Responsible for site compliance and is the primary interface during audits and interactions with regulators.
• This position is accountable to the DVP QA, Site Operations head and divisional and Corporate Quality for achieving mutually agreed objectives on a timely basis. Decisions and recommendations made by this position have a direct impact on products for domestic and international sales. Must effectively communicate, prepare, and negotiate both internally with site and divisional personnel and externally with various regulatory agencies. Position impacts operations through GMP compliance requirements and activities such as audits, training, etc. Failure to maintain a Quality System compliance to the QSR can lead to warning letter or more severe regulatory actions resulting in multi-year impact. Control budget and quality costs. Authorize cost efficiency projects that maintain compliance and alignment with QS requirements while contributing to Division margin improvement initiatives.

Benefits

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
• Free coverage applies in the next calendar year.
• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees