Quality Manager, Portfolio Expansion - 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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

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. 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 FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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.

The Quality Manager, Portfolio Expansion role is responsible for supporting the expansion of Abbott Nutrition's Third-Party Manufacturer (TPM) portfolio through all stages of qualification. This requires collaboration with cross-functional personnel to lead and actively support activities through TPM selection, evaluation, approval, and first commercial run. The position also acts as the main AN Quality point of contact during the entire qualification process. This requires establishing a robust long-term working quality relationship with the TPM and ensuring that start-up project activities are carried out within the agreed targets with the assigned TPM.

This position is responsible for assuring TPMs have an effective Quality Management System that meets applicable regulatory requirements and industry food safety requirements. Failure to do so can cause food safety or quality issues that may lead to on-market events that negatively impact customer health and customer perception of the brand. Also, the inability of the TPM to comply with the Quality System can greatly impact AN division inventory levels and the ability to service customer demands.

Responsibilities

• Collaborating with TPM operations and process engineering groups in performing site assessments of potential TPMs
• Conducting food safety and quality system audits of potential TPMs
• Tracking and closing of corrective actions from audits
• Identifying and elevating food safety and project risks associated with the qualification of a new TPM
• Participating in the overall commercial project for launch of products at new TPMs
• Managing the quality related project deliverables of the overall commercial project
• Creating Standard Manufacturing Plans (SMPs) to provide specification and manufacturing details to the TPM
• Coordinating with Global Supplier Quality to assure qualification of new ingredients and packaging
• Negotiating initial Quality Agreements with new TPMs
• Participating in product FMEAs by providing input on details of the TPMs quality system and processes
• Aligning the TPM quality processes with AN quality expectations and quality systems
• Releasing first commercial batches for distribution including assuring proper investigation and corrective actions for any nonconformances or potential nonconformances
• Transitioning new TPMs to the TPM QA group who supports business as usual activities

Education and Experience

Required

• Bachelor's degree, preferably in a science, engineering, or life/physical sciences
• At least 7 years of experience in a Quality Assurance, Supplier Quality Management, Compliance, Quality Systems or closely related position with application of GMP regulations
• Demonstrated leadership skills/competencies with a track record of success
• Demonstrated experience successfully interacting and communicating with all organizational levels internally and externally (e.g. third-party manufacturers or external regulatory bodies)
• Demonstrated ability to manage several activities / projects at once, organize / prioritize work

Preferred

• Previous auditing experience is strongly preferred
• Experience in a manufacturing facility is preferred with that experience in an Abbott Nutrition manufacturing site being strongly preferred
• Experience with creating, executing, or auditing Food Safety or HACCP plans is strongly preferred
• Experience within a federally regulated industry. Food (infant formula and nutritional) industry is strongly preferred
• Thorough knowledge of different manufacturing processes and quality assurance principles; with the ability to comply with internal procedures and federal regulations

Apply Now

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.

Connect with us at abbott.com , on LinkedIn at , and on Facebook at .

The base pay for this position is

$97,300.00 $194,700.00

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

JOB FAMILY: Project Management DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Columbus : 2900 Easton Square Place ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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: