Director QA

Abbott   •  

Columbus, OH

11 - 15 years

Posted 178 days ago

This job is no longer available.

JOB DESCRIPTION:

Realize your full potential while helping others achieve theirs.

At Abbott, we're committed to helping people live their best possible life through the power of health.  For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.  Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Director, Plant Quality Assurance – Columbus, Ohio

Nutrition is the foundation for living the best life possible.  People around the globe rely on our science-based nutrition products - like Similac, PediaSure, Pedialyte, Ensure, Glucerna, EAS and ZonePerfect - to live their best and fullest lives.  Whether it’s a parent nourishing a newborn or an older adult using nutritional products to stay strong, they place their trust in us.  That’s why we are committed to food safety and ensuring the highest quality standards.  Quality is at the heart of everything we do.

We are looking for a Director, Plant Quality Assurance at our manufacturing site in Columbus, Ohio.  As a part of the site’s leadership team, you would also join a global team of professionals who come to work every day with energy and enthusiasm because they know that what they we do is meaningful to all those who depend on our company and our products.  We’ve created a unique culture that values the contributions of all employees, strives to continuously improve and supports growth and development.  Come join our team and reach your full potential.

Main Responsibilities

  • Lead the Quality function and drive Quality System execution to achieve compliance with Corporate and Division requirements.
  • Establish and implement Quality Assurance procedures for inspecting and controlling raw or packing materials and assaying in-process and finished product to ensure that all products generated conform to predetermined Corporate/Division standards and specifications.
  • Oversee cGMP, site quality standards and corresponding risk assessments and QA change control processes related to the manufacturing, testing and release of a variety of nutritional products.  
  • Ensure the manufacturing site has the system knowledge, capabilities and practices to comply with all internal Quality Assurance and Food Safety policies and procedures in addition to all pertinent FDA, USDA, State and customer requirements.
  • Direct interface with the FDA, USDA, and various global, state and local agencies.  Interfaces with external suppliers and vendors as well as external government and industry forums. Monitors and reports on activities of the plant Quality System to Division QA.  Drive Continuous Improvement using Quality Analytics to monitor leading and lagging indicators of Quality and Food Safety.
  • Ensure Food Quality and Food Safety Plans are current, relevant and are being followed and implemented.  Ensure all HACCPs are appropriate and records are complete and accurate. Monitor CAPA (Corrective and Preventive Action) Programs to ensure Root Cause analysis is performed and timely closure.
  • Lead the quality activities at the site ensuring the appropriate staffing is available at all times and skills and competencies are consistent with present and future needs. Conducts value analyses to optimize use of these resources. 
  • Monitor, audit and approve facilities and manufacturing operations for conformance with established procedures and requirements of the Corporate and Governmental GMPs, such as Low Acid Food and Infant Formula Regulations. 
  • Ensure maintenance of required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, state and federal regulations.
  • Support plant and division activities in introducing new products through the plant and clinical products for testing and data evaluation, and major plant project expansions and new products to ensure proper technical input and regulatory requirements are met.
  • Management responsibility for complex laboratories which include chemical, biological, sterility and environmental testing. 
  • Interfaces with appropriate Division QA functions and key stakeholders to understand and troubleshoot product complaints and improve customer service/product performance.

Education

  • Bachelor’s Degree required. Chemistry, Chemical Engineering, Biology, Bacteriology or other technical degreepreferred.  Master’s Degree preferred.

Qualifications

  • Minimum of 10 years of direct experience in food or related industry is required.
  • Minimum of 5 years of people leadership experience with a track record of developing talent and creating a high-performing team environment.
  • Must possess a thorough knowledge of and have at least 5 years’ experienceapplying FDA/GMP regulations. 
  • Prior Quality System experiencerequired.
  • Demonstrated ability to drive continuous improvement and manage to/achieve metrics.
  • Strong communication skills with the ability to interact effective with all levels of employees, peers and senior leaders.
  • Excellent problem solving, risk assessment and decision making skills are also critical to this position, since the technology for many of Abbott Nutrition products are unique.
  • Ability to provide after-hours support to a 24 x 7 operation for critical issues.

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