Program Manager Third Party Manufacturing (TPM) Quality 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 109,000 colleagues serve people in more than 160 countries.

Program Manager Third Party Manufacturing (TPM) Quality Assurance

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

Our location in Columbus, OH, currently has an opportunity for a Program Manager Third Party Manufacturing (TPM) Quality Assurance

WHAT YOU'LL DO

Primary Function / Primary Goals / Objectives:
  • The Third-Party Manufacturing Quality Assurance Program Manager coordinates and supervises the Quality Assurance Department in accordance with Corporate and Divisional standards in order to assure that proper controls are instituted and maintained by the third-party manufacturers on incoming and in-process materials and finished product utilizing powder operation processes and retort product.
  • Overall responsibility to maintain high quality levels on all products while achieving high efficiency.
  • The Manager is responsible for oversight of the TPM GMP compliance, manufacturing quality, laboratory support, product testing and release, Vendor Quality, documentation, label control and quality planning.
  • Post-production responsibilities include product surveillance throughout shelf life and monitoring and remediation of consumer complaints.
  • The scope of the primary function of the Program Manager includes domestic and
  • international nutrition TPM Operations.

Major Responsibilities:
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Establishes and implements Quality Assurance policies and procedures for inspecting and controlling raw or packing materials and assaying in-process and finished product to insure that all products generated conform to predetermined Corporate/Division standards and specifications.
  • In conjunction with Division Compliance, monitors facilities and manufacturing operations for conformance with established procedures and requirements of regulations.
  • Insures that required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, regulatory inspections are maintained.
  • Supports plant and Division activities in introducing new products through the plant and clinical products for testing and data evaluation. Supports major plant project expansions and new products to assure proper technical input and regulatory requirements.
  • Management oversight for TPM laboratories which include chemical, biological, sterility and environmental testing.
  • Interfaces with Division to understand and troubleshoot product complaints and improve customer service/product performance.
  • Responsible for the plant validation program and assures that it is consistent with division validation policies.
  • Provides a Vendor Quality oversight to assure that suppliers have appropriate quality systems and process controls to guarantee the delivery of usable inventories of the needed quality

Education:
  • Bachelor's Degree in Chemistry, Chemical Engineering, Biology, Bacteriology or other technical degree is required. Master's Degree preferred but not required.

Required:
  • Candidate must have demonstrated leadership skills/competencies with track record of success. Excellent communication skills are also essential for this role.
  • A minimum of five years of supervisory management background.
  • The incumbent should possess a thorough knowledge of and has at least five years' experience in application of GMP regulations.
  • Communications skills, tack and diplomacy are critical to the performance of position requirements.
  • Excellent problem solving, decision making skills are also critical to this position, since the technology for many of Abbott's products are unique.
  • Challenges may be unique or previously unmet.

Preferred:
  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

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