Manager, TPM QA Copacking & Pediatric Accessories - Columbus, OH

Abbott • Columbus, OH

1d • Onsite

About The Position

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®, 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.

The Third-Party Manufacturing Quality Assurance Program Manager coordinates and supervises the Quality Assurance Department in accordance with Corporate and Divisional standards to assure that proper controls are instituted and maintained by the third-party manufacturers on incoming and in-process materials and finished product. Overall responsibility to maintain high quality levels on all co-packed and pediatric accessory products while achieving high efficiency. The Manager is responsible for oversight of the TPM GMP compliance, manufacturing quality, laboratory support, product testing, 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 co-packing and pediatric TPMs.

Requirements

• Bachelor’s Degree in Package Engineering, Industrial Engineering, Mechanical Engineering, or other technical degree is required.
• Candidate must have demonstrated leadership skills/competencies and excellent communication skills with track record of success.
• A minimum of three 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.

Nice To Haves

• Master’s Degree preferred but not required.
• Knowledge of applicable regulatory standards and requirements for co-packing, blister packing, and rubber manufacturing.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Establishes and implements Quality Assurance policies and procedures for inspecting and controlling packing materials and in-process and finished product to ensure 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 inspections, file samples, vendor performance, product complaints, product disposition, and regulatory inspections are maintained.
• Supports plant and Division activities in introducing new products within the TPM network.
• Supports major plant project expansions and new products to assure proper technical input, quality assurance controls and regulatory requirements are in place.
• Interfaces with Division to understand and troubleshoot product complaints and improve customer service/product performance.
• Provides a Vendor Quality oversight to assure that TPMs have appropriate quality systems and process controls to guarantee the delivery of usable inventories of the needed quality.
• Develops and maintains internal Quality Assurance documentation to insure process and procedural compliance in support of TPM activities.

Benefits

• Training and career development , with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation
• 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 of 5%
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees