Senior Project Lead 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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION Senior Project Lead Quality Assurance Working at Abbott 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 them get the nutrients they need to live their healthiest lives. 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 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 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 location in Columbus, OH currently has an opportunity for a Project Lead Quality Assurance. As a Senior Project Lead within QA, the individual will be responsible for supporting the complaint management quality system. In this role the individual will be responsible for tracking, trending, analytics, and metric reporting for global complaint data. Additionally, the individual will be expected to develop into a division SME for complaint management; identify and lead process improvement projects for our complaint handling process; and oversee the data used in the complaint handling process to drive compliance. The candidate must be capable of working under general direction while leveraging input from manager and stakeholders. The candidate must demonstrate the willingness to learn the business, challenge the status quo and balance priorities while keeping a positive and inquisitive mind‑set. The role is critical in sustaining the business’s ability to appropriately process complaints, analyze complaint data, and detect potential signals for AN product on market (globally). WHAT YOU’LL DO Perform routine tracking and trending for complaints. Evaluate complaint data to make proposals and decisions. Elevate concerns appropriately. Review trending decisions and investigations. Complete metric reporting with a high level of accuracy. Lead department trend meetings. Create QRs in ABTRAQ for tracking and trending. Develop, design, and run reports and data to fulfill ad hoc requests. Determine the best approach for extracting data to fulfill requests. Establish annual complaint thresholds using statistical data analysis. Own PowerBI and COGNOS reports. Offer improvement recommendations to streamline and simplify. Work with IT to plan and execute validation changes and proposed changes. Perform user acceptance testing for IT systems supporting complaint management such as Trackwise, DataMart, and Power BI. Support the development of user requirements for IT systems, reports, and databases. Help users obtain access to owned systems and maintain user groups. Register agency complaints as needed. Understand the full complaint process including review and approval of access requests. Monitor data to ensure it is correctly loaded. If discrepancies are found, follow through with clean up and ensure correct information is reloaded. Initiate IT tickets to correct data loading errors and notify impacted users. Demonstrate basic project management skills by acting as a project lead on small to medium, well defined projects. Provide guidance to less experienced staff. Plans, organizes, and prioritizes own daily work routine to meet established schedule. Exercises authority and judgment within defined limits to determine appropriate action. Oversees operational implementation of quality assurance strategies. Completes the assessment of potential risks, ensures compliance, and gives recommendations to management. Participates in audits and regulatory inspections. Makes recommendations for continuous improvement opportunities with data reports and modeling. Identifies opportunities to improve the efficiency and effectiveness of the systems and processes being examined (process improvement/reengineering projects). Provide training and feedback to the business for PowerBi reports and procedurally driven initiatives. Maintain Division complaint responsibilities for the database used for FDA reporting Manage available sites and corresponding data in the DataMart (adding and removing new sites and lines). Required Qualifications Bachelor’s Degree in Data Analytics, Statistics, Engineering, or equivalent. 1 - 3 years of Experience with Power BI, Minitab, and other data modeling and data analytics tools. Demonstrated performance and results in continuous improvement efforts and risk reduction. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi‑tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow‑up skills and ability to hold others accountable. Preferred Qualifications Experience in an AN plant. Experience in audits from regulatory and certification bodies. Experience in software verification and validation. Experience supporting a global team. Demonstrated and impactful project management skills. Experience with Cognos/SQL, Access, and database development. MISC: This is an on‑site role - not a remote role. There is no relocation provided for this role. Please note this position could be a grade 15 based on qualifications. The base pay for this position is $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted. 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. EEO is the Law link - English: EEO is the Law link - Espanol: 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. #J-18808-Ljbffr Abbott Laboratories