Manager Quality Assurance – US Distribution Quality - Columbus. OH

Abbott•Columbus, OH

9d•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®, and Glucerna® – to help get the nutrients they need to live their healthiest life. At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 high employer contribution 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.

Requirements

Minimum 4-year college degree
7 + years’ experience
Managing direct reports experience
Quality compliance/CAPA experience
Logistics distribution experience
FDA or GMP Regulation experience

Responsibilities

Oversee (6) Distribution Quality Assurance (QA) Direct Reports + (2) Indirect Reports
Implement quality standards and manage ongoing compliance for US Distribution.
Provide Quality Leadership to US Third-Party and Abbott-Managed Warehouses
Site Qualification and Audit Management - Lead evaluation/startup of new third-party warehouses and approval of respective warehouse quality agreements
Monitor Ongoing Compliance Elevations - Audit observations, transportation or distribution events, temperature excursions, applicable registrations, operational challenges, risk assessments, etc.
Approve Quality Records for Root Cause Analysis (RCA) / Corrective Action Plans (CAPA) - Address any gaps in compliance from end-to-end through the division quality record process
Division Material Controls Quality System Ownership - Maintain Quality System playbook, perform global impact assessments
Lead Distribution QA Product Action Playbook Tasks
Develop Strategy and Process Improvement Leadership
Communications - Adjust communication style upwards and downwards, stakeholder management
Cross-functional Communications - Division Quality, Logistics, Manufacturing Plants, Legal, Regulatory, Commercial, Procurement, external Third-Parties, etc.
Backup to Quality Hold execution, lot traceability reporting, and Finished Goods compliance activities