Complaints Handling Manager, U.S. Region - Columbus, OH

Thornton Tomasetti; Columbus (OH); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott is seeking a Complaints Handling Manager for the U.S. Region, based in Columbus, OH. This role leads quality systems for laboratory and complaint handling, driving compliance and continuous improvement across the U.S. investigations and manufacturing interfaces.

The candidate will manage a team, implement QA policies, coordinate audits, respond to findings, and drive CAPA activities while partnering with cross-functional teams and external vendors.

Qualifications

• Bachelor's Degree (± 16 years).
• Food Science, Engineering, Microbiology, Biology, or Chemistry.
• Minimum 7 years.
• Food and Infant Formula industry, leading a team with little direction, quality system ownership, and laboratory.
• Experience within a manufacturing plant is a plus.

Responsibilities

• Develops quality assurance policies, strategies and regulations related to laboratory and complaint handling in the U.S.
• Assesses potential risks, ensures compliance and gives recommendations.
• Takes responsibility and manages team for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, finished product or services).
• Facilitates audits, agency complaints, and regulatory inspections related to product manufactured in/shipped to the U.S.
• Respond to audit findings.
• Works with broad group of internal cross functional partners to ensure compliance, positive investigation outcomes, and timely execution.
• Meet with customers and HCPs (Healthcare Providers), as needed.
• Escalate complaints and investigation outcomes appropriately.
• Participate in on market evaluation process.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Coordinates quality trainings.
• Prepare, develop, monitor, and report on monthly, quarterly, and annual metrics related to area of responsibility.
• Perform ongoing complaint monitoring and data trending related to product manufactured in/shipped to the U.S.
• Provide timely feedback on complaint inputs and investigations.
• Process, assess, and approve complaints related to product manufactured in/shipped to the U.S; prepare written responses.
• Develop and provide feedback on complaint handling standards.
• Initiate and investigate CAPAs when necessary.

Skills

Quality assurance

Regulatory compliance

Audits

CAPAs

Team leadership

Education

Bachelor's Degree

Food Science

Engineering

Microbiology

Biology

Chemistry

Job description

JOB DESCRIPTION: Complaints Handling Manager, U.S. Region

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 122,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. Our Nutrition business develops science-based products for people of all ages—from helping babies and children grow to keeping adult bodies strong and active. Millions around the world rely on our leading brands, including Similac, PediaSure, Pedialyte, Ensure, and Glucerna, to live their healthiest lives.

Working at Abbott

At Abbott, you can do work that matters, grow and learn, care for yourself and your 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 a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit—an affordable and convenient path to earning a bachelor’s degree.
• Recognition globally as a great place to work, and for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of Columbus, OH in the Nutrition Division. The Complaints Handling Manager, U.S. Region will implement quality standards, ensure and execute compliance on every stage of the process. Manage the complaint handling quality system for product manufactured in/shipped to the U.S. and the Complaint Laboratory in the U.S.

WHAT YOU’LL DO

• Develop and implements quality assurance policies, strategies and regulations related to laboratory and complaint handling in the U.S.
• Assesses potential risks, ensures compliance and gives recommendations.
• Takes responsibility and manages team for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, finished product or services).
• Facilitates audits, agency complaints, and regulatory inspections related to product manufactured in/shipped to the U.S.
• Respond to audit findings.
• Works with broad group of internal cross functional partners to ensure compliance, positive investigation outcomes, and timely execution.
• Meet with customers and HCPs (Healthcare Providers), as needed.
• Escalate complaints and investigation outcomes appropriately.
• Participate in on market evaluation process.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Coordinates quality trainings.
• Prepare, develop, monitor, and report on monthly, quarterly, and annual metrics related to area of responsibility.
• Perform ongoing complaint monitoring and data trending related to product manufactured in/shipped to the U.S.
• Provide timely feedback on complaint inputs and investigations.
• Process, assess, and approve complaints related to product manufactured in/shipped to the U.S; prepare written responses.
• Develop and provide feedback on complaint handling standards.
• Initiate and investigate CAPAs when necessary.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor's Degree (± 16 years).
• Food Science, Engineering, Microbiology, Biology, or Chemistry.
• Minimum 7 years.
• Food and Infant Formula industry, leading a team with little direction, quality system ownership, and laboratory.
• Experience within a manufacturing plant is a plus.

The base pay for this position is $99,300.00 – $198,700.00

JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Columbus : 2900 Easton Square Place ADDITIONAL LOCATIONS:

WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Abbott welcomes and encourages diversity in our workforce.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

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Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.