Technical Program Manager Quality Systems 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 122000 colleagues serve people in more than 160 countries.

Technical Program Manager - Quality Systems

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Our Nutrition business develops science-based products for people of all agesfrom 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.

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. Youll 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 benefitan affordable and convenient path to earning a bachelors 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 Nutritions 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 Nutritions 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 and 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 YOULL DO

• Lead the planning development execution and continuous improvement of global equipment and facility-based Quality System programs to support Abbott Nutritions 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

• 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

• Build the case-for-change 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 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 YOULL BRING

Required:

• Bachelors 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%

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

$113300.00 $226700.00

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

Project Management

ANSC Nutrition Supply Chain

United States > Columbus : 2900 Easton Square Place

Standard

Yes 25 % of the Time

No

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.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

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