Technical Program Manager - Quality Systems

Thornton Tomasetti; Columbus (OH); On-site; USD 129,000 - 259,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott Nutrition’s Global Engineering, Manufacturing Technology & Innovation team in Columbus, OH seeks a Technical Program Manager - Quality Systems to lead global QMS programs across manufacturing, engineering and regulatory functions. This role partners with sites worldwide to ensure compliance and continuous improvement of quality systems.

The position requires strong leadership, data-driven decision making, and the ability to drive strategic quality initiatives in a complex, regulated

Qualifications

• Bachelor's degree in Engineering, Food Science, Microbiology, Quality Assurance, Life Sciences, or related technical discipline.
• 10+ years of experience in quality systems, quality assurance, manufacturing, engineering, regulatory compliance, or related technical leadership roles.
• Demonstrated expertise in Quality Management Systems, GMPs, quality risk management, audit programs, corrective and preventive action systems, and regulatory compliance within regulated manufacturing environments.
• Strong knowledge of applicable regulatory requirements and quality standards governing infant formula, nutritional products, food manufacturing, or comparable regulated industries.
• Relevant technical background or subject matter expertise in design, commissioning, and validation of buildings/facilities/utilities, equipment and/or production processes for nutritional products or similar industries is preferred.
• Experience leading complex cross-functional programs and initiatives in a global organization.
• Proven ability to monitor quality system performance, identify risk trends, drive continuous improvement, and implement effective preventive and corrective actions.
• Strong strategic thinking and decision-making skills with the ability to balance quality, compliance, business, and operational objectives.
• Demonstrated success influencing stakeholders and obtaining alignment across multiple functions and levels of leadership.
• Excellent analytical, problem-solving, facilitation, and project management skills.
• Experience supporting regulatory inspections, third-party audits, and enterprise-level quality transformation initiatives.
• Strong verbal and written communication skills with the ability to communicate complex technical concepts to diverse audiences, including executive leadership.
• Ability to work collaboratively in a fast-paced, highly matrixed global environment.
• Self-directed, results-oriented professional with a strong sense of ownership and accountability.
• Knowledge of digital quality systems, data analytics, and quality performance dashboards.
• Ability to travel up to 25%

Responsibilities

• Lead the planning, development, execution, and continuous improvement of global equipment and facility-based Quality System programs to support Abbott Nutrition’s operational, engineering, quality, and regulatory objectives.
• Serve as the Quality System subject matter expert and strategic owner for technical QMS subsystems, ensuring long-term effectiveness, sustainability, performance, and alignment with business objectives and regulatory requirements.
• Provide technical leadership and guidance to manufacturing sites, quality organizations, engineering teams, and project teams regarding Quality System requirements and implementation strategies.
• Act as the document owner for assigned Quality System elements, maintaining policies, procedures, standards, and processes to ensure alignment with regulatory expectations and Abbott Quality Requirements (AQR).
• Support sites globally to ensure local procedures and practices are aligned with enterprise-level quality requirements and expectations.
• Develop and maintain quality system metrics and reporting tools that provide visibility to leadership and support effective decision-making.
• Monitor the health and performance of technical Quality Systems using data-driven approaches to identify trends, emerging risks, and opportunities for improvement before failures occur.
• Anticipate and understand business challenges, proactively identifying tactical and strategic risks while developing effective mitigation plans.
• Evaluate the impact of regulatory changes, industry trends, and emerging best practices on assigned Quality Systems and drive implementation of required changes.
• Provide consultation for the successful resolution of audit observations, investigations, and corrective actions, including evaluation and replication of improvements across the Abbott Nutrition network.
• Provide Quality System impact assessments and technical recommendations for significant projects, regulatory changes, remediation activities, and business initiatives.
• Serve as a representative for Abbott Nutrition with AQR, external auditors, industry organizations, and other Abbott divisions as appropriate.
• Coordinate stakeholder engagement, governance activities, and cross-functional alignment for quality system programs and initiatives.
• Benchmark internal and external best practices and leverage cross-functional and cross-divisional learnings to improve quality system effectiveness.
• Act as a change champion for technical Quality System elements and support adoption of new processes, technologies, and business practices.
• Develop and maintain business continuity plans including training programs, playbooks, documentation, succession planning, and knowledge transfer resources to ensure long-term sustainability of assigned systems.
• Provide leadership, coaching, and mentoring to quality, manufacturing, and engineering personnel across the organization.

Skills

Quality management

Regulatory compliance

GMPs

Audit programs

CAPA

Quality risk management

Data analytics

Project management

Education

Bachelor's degree in Engineering, Food Science, Microbiology, Quality Assurance, Life Sciences, or related technical discipline

Tools

Quality Management Systems

Job description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION: Technical Program Manager - Quality Systems

Abbott is a global healthcare leader, creating breakthrough science to improve people's health.

Our Nutrition business develops science-based products for people of all ages—from helping babies and children grow to keeping adult bodies strong and active. Millions around the world rely on our leading brands, including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®, to live their healthiest lives.

Working at Abbott At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit—an affordable and convenient path to earning a bachelor’s degree. Recognition globally as a great place to work, and for diversity, working mothers, female executives, and scientists.

The Opportunity This position works out of our Columbus, OH in the Nutrition Division.

This role within Abbott Nutrition’s Global Engineering, Manufacturing Technology & Innovation (MT&I) team leads the global governance, strategic direction, and continuous improvement of enterprise Quality Management System (QMS) programs supporting Abbott Nutrition's manufacturing, engineering, and innovation network.

The Technical Program Manager - Quality Systems is responsible for ensuring the effectiveness, sustainability, and regulatory compliance of technical (Buildings, Facilities, Utilities, and Equipment) Quality System (QS) elements while aligning quality strategies with engineering requirements and business objectives.

This role serves as a key advisor to leadership, drives enterprise-wide quality system improvements, and partners with manufacturing, quality, engineering, and regulatory stakeholders to strengthen the overall quality framework across Abbott Nutrition.

WHAT YOU’LL DO

• Lead the planning, development, execution, and continuous improvement of global equipment and facility-based Quality System programs to support Abbott Nutrition’s operational, engineering, quality, and regulatory objectives.
• Serve as the Quality System subject matter expert and strategic owner for technical QMS subsystems, ensuring long-term effectiveness, sustainability, performance, and alignment with business objectives and regulatory requirements.
• Provide technical leadership and guidance to manufacturing sites, quality organizations, engineering teams, and project teams regarding Quality System requirements and implementation strategies.
• Act as the document owner for assigned Quality System elements, maintaining policies, procedures, standards, and processes to ensure alignment with regulatory expectations and Abbott Quality Requirements (AQR).
• Support sites globally to ensure local procedures and practices are aligned with enterprise-level quality requirements and expectations.
• Develop and maintain quality system metrics and reporting tools that provide visibility to leadership and support effective decision-making.
• Monitor the health and performance of technical Quality Systems using data-driven approaches to identify trends, emerging risks, and opportunities for improvement before failures occur.
• Anticipate and understand business challenges, proactively identifying tactical and strategic risks while developing effective mitigation plans.
• Evaluate the impact of regulatory changes, industry trends, and emerging best practices on assigned Quality Systems and drive implementation of required changes.
• Provide consultation for the successful resolution of audit observations, investigations, and corrective actions, including evaluation and replication of improvements across the Abbott Nutrition network.
• Provide Quality System impact assessments and technical recommendations for significant projects, regulatory changes, remediation activities, and business initiatives.
• Serve as a representative for Abbott Nutrition with AQR, external auditors, industry organizations, and other Abbott divisions as appropriate.
• Coordinate stakeholder engagement, governance activities, and cross-functional alignment for quality system programs and initiatives.
• Benchmark internal and external best practices and leverage cross-functional and cross-divisional learnings to improve quality system effectiveness.
• Act as a change champion for technical Quality System elements and support adoption of new processes, technologies, and business practices.
• Develop and maintain business continuity plans including training programs, playbooks, documentation, succession planning, and knowledge transfer resources to ensure long-term sustainability of assigned systems.
• Provide leadership, coaching, and mentoring to quality, manufacturing, and engineering personnel across the organization.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Required: Bachelor's degree in Engineering, Food Science, Microbiology, Quality Assurance, Life Sciences, or related technical discipline
• 10+ years of experience in quality systems, quality assurance, manufacturing, engineering, regulatory compliance, or related technical leadership roles
• Demonstrated expertise in Quality Management Systems, GMPs, quality risk management, audit programs, corrective and preventive action systems, and regulatory compliance within regulated manufacturing environments
• Strong knowledge of applicable regulatory requirements and quality standards governing infant formula, nutritional products, food manufacturing, or comparable regulated industries
• Relevant technical background or subject matter expertise in design, commissioning, and validation of buildings/facilities/utilities, equipment and/or production processes for nutritional products or similar industries is preferred.
• Experience leading complex cross-functional programs and initiatives in a global organization
• Proven ability to monitor quality system performance, identify risk trends, drive continuous improvement, and implement effective preventive and corrective actions
• Strong strategic thinking and decision-making skills with the ability to balance quality, compliance, business, and operational objectives
• Demonstrated success influencing stakeholders and obtaining alignment across multiple functions and levels of leadership
• Excellent analytical, problem-solving, facilitation, and project management skills
• Experience supporting regulatory inspections, third-party audits, and enterprise-level quality transformation initiatives
• Strong verbal and written communication skills with the ability to communicate complex technical concepts to diverse audiences, including executive leadership
• Ability to work collaboratively in a fast-paced, highly matrixed global environment
• Self-directed, results-oriented professional with a strong sense of ownership and accountability
• Knowledge of digital quality systems, data analytics, and quality performance dashboards
• Ability to travel up to 25%

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.

JOB FAMILY: Project Management DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Columbus : 2900 Easton Square Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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.

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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