Sr. Manager North America Design Assurance - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Senior Manager North America Design Assurance

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.

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®, and Glucerna®– to help get the nutrients they need to live their healthiest life.

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’ll also have access to:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plan
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
• Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 5 personal days + 10 paid holidays
• 401(k) retirement savings with a generous company match
• Tuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor’s degree.
• 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities.

The Opportunity

Our Design Assurance team currently has an opportunity for a Sr Manager, North America Design Assurance . This position will be based in Columbus, OH. This manager will have Design Assurance department management responsibility for US based team members that support Abbott Nutrition Adult and Pediatric medical nutritional products produced at Abbott Nutrition North America manufacturing sites. Our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life.

This Design Assurance department leader must effectively manage their team in accordance with Corporate and Divisional policies and procedures to ensure that proper controls are instituted and maintained. The manager will provide leadership as needed for QA initiatives to implement quality systems/processes across Abbott Nutrition (AN) achieving quality improvements, cross plant consistency, and regulatory compliance. The manager is responsible for the use of strong, integrated, quality design principles to deliver innovation & support product lifecycle analysis at AN or third-party manufacturing sites. The manager has direct accountability for AN product quality, medical safety, and compliance to global regulatory requirements during design and development and provides support to established products. This role requires the ability to manage cross functional partnerships for new product introductions (avg. 40+ active projects at one time) and on-going product lifecycle management. Their decision-making impact has direct result on AN division goal including margin (strategic cost improvement projects), sales (innovation programs), and people (development & accountability).

What You’ll Work On

• Lead and develop a high-performing team to execute across multiple concurrent programs, ensuring delivery against operational, quality, and compliance objectives.
• Ensure end-to-end compliance with corporate, divisional, and regulatory requirements across quality systems, product outputs, and incoming materials through effective governance, documentation, and monitoring.
• Drive new product introduction (NPI) and lifecycle performance by leading team execution and partnering cross-functionally to support innovation, product performance monitoring, and business growth initiatives.
• Provide global operational and quality leadership by supporting plant, quality assurance, and supply chain functions, and leading event management activities as needed.
• Oversee product qualification and validation activities to ensure alignment with divisional programs, standards, and strategic initiatives.
• Manage team performance against objectives, budgets, and operating plans, implementing corrective actions to ensure sustained results.
• Lead continuous improvement efforts by designing and executing programs that enhance performance, efficiency, and long-term compliance.

Accountability / Scope / Budget

• Under the guidance of the Director of Design Quality Assurance, this position is responsible for compliance with Corporate and Divisional QA policies, procedures, standards and specifications as well as regulations in applicable countries of operation.
• Responsible for strategic innovations and lifecycle product quality management for 100+ different formulations out of any of the US-Based manufacturing sites.
• This position may have up to 8 direct reports.

EDUCATION AND EXPERIENCE, YOU’LL BRING

• Education: Bachelor’s degree in applied, physical, or life science, engineering or business. Master’s degree is a plus.
• A minimum of 7 years of experience in Quality, Supply Chain and Manufacturing, or related experience is desired. 

• Demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience.
• Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP).
• Knowledge of quality management systems and regulatory standards as required by the Code of Federal Regulations (CFR) – US, CODEX, as well as international country regulatory bodies as appropriate for nutritional, drug, and dietary supplement products.
• This position requires excellent problem solving and decision-making skills as Abbott's products are unique.
• This position requires a thorough understanding of integrated processes and technologies involved in supply management is required. 
• The manager must be capable of interpreting and analyzing technical data for decision making.
• The manager must have the ability to summarize and present technical recommendations and solutions to Abbott senior management.

MISC:

• This is not a remote role but an onsite role.

* 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:

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.

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The base pay for this position is $129,300.00 – $258,700.00. In specific locations, the pay range may vary from the range posted.