Validation Program Manager - Columbus, OH - Abbott
Columbus, OH 43291
About the Job
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.Validation Program ManagerNourish the world and your career as part of the Nutrition team 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, Glucerna and ZonePerfect to help get the nutrients they need to live their healthiest life.WORKING AT ABBOTTAt Abbott, you can have a good job that can grow into a great career. We offer:
• Fast paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• 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 year is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 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.Learn more about our benefits that add real value to your life to help you live fully: What You'll Do:Manage the Validation program for the Strategic Capacity Expansions organization to ensure the success of large-scale capital projects.Develop Validation Strategy for multi-million-dollar capital investments programs and gain cross-functional leadership alignment throughout all design phases.Provide guidance on validation and design control strategies; guidance on product, process, equipment changes, which may or may not require a design change and/or re-validation.Actively manages the project validation and design quality engineering teams (internal, external, VSPs) to ensure successful execution.Develops structure and metrics required to monitor the progress, adherence and compliance of the change, validation, and design control processes. Escalate issues when necessary.Navigates challenges that emerge between project execution and policy requirement intent to a compliant outcome.Supports PM to execute validation resource planning and validation support structure.Support the development, manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers. Assure that the team has policies, processes and procedures in place so that project activities, with regards to design control, process validation and change control, meet applicable quality and regulatory standards, divisional and local requirements.Work closely with the Technical, Engineering, Quality and Research & Development functions in order to ensure changed or new product/processes are implemented in compliance with AN, Corporate and GMP requirements, and in a timely manner to ensure AN business goals are met. Provide visibility and education to the team to ensure proper monitoring and alarming of CPPs through all design phases.Act as a Subject Matter Expert (SME) or represent SME for change, validation and design control processes. Act as a Subject Matter Expert (SME) for application of statistical sampling plans, Design of Experiments (DOE) and design and process failure modes and effects analysis (FMEA). Ensure training requirements are met and that members of the team stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents. Work with the team to understand the root cause of the unexpected outcomes and the impact to approved URS to determine potential solutions that ensure compliance, maintain the integrity of the validation process and enable the team to work towards its goals and objectives.Validation strategy for significant 100+MM and include 1.2B Capital Investments. This individual will make decisions about: overall strategy for validation encompassing all phases and scope of the project/program, external VSP to contract for projects, allocation of effort to internal and external resources, design of experiments (DOE), Statistical Sampling Plans, acceptability of validation results, solutions and way forward when activities do not go as planned.Lead a team of professionals ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct. Develop and maintain validation competency and knowledge within project team.Ensure that quality/compliance issues are highlighted, and Quality decisions are made in a timely manner to facilitate new/changed product supply. Oversee the review and approval of change processes, validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements. Establish service level agreements to ensure timely completion and monitor teams’ performance in support of the site’s validation, design control and on market change projects to ensure best speed to market for new/changed products. Implement site change, validation, and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks. Ensure the expertise and material is available to be able to deploy change, validation, and design control training to the site. Work with corporate, divisional, and capacity expansion teams to ensure the utilization and improvement of consistent, best practice validation and design control policies and procedures. Manage the Validation & Design QA budget to ensure spending is within agreed limits; maintain awareness of financial performance; support the development of cost-efficient business processes whilst ensuring compliance and quality requirements are met.Education: Bachelor's degree3-5 years Validation and Design Control System experience2 years Quality Management experienceApply Now!* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.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 and a Military/Veteran Friendly employer.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.Job SummaryJob number: 31062398Date posted : 2023-07-20Profession: QualityEmployment type: Full time
• Fast paced work environment where your safety is our priority
• Production areas that are clean, well-lit and temperature-controlled
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• 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 year is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Company Paid Pension Plan
• 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.Learn more about our benefits that add real value to your life to help you live fully: What You'll Do:Manage the Validation program for the Strategic Capacity Expansions organization to ensure the success of large-scale capital projects.Develop Validation Strategy for multi-million-dollar capital investments programs and gain cross-functional leadership alignment throughout all design phases.Provide guidance on validation and design control strategies; guidance on product, process, equipment changes, which may or may not require a design change and/or re-validation.Actively manages the project validation and design quality engineering teams (internal, external, VSPs) to ensure successful execution.Develops structure and metrics required to monitor the progress, adherence and compliance of the change, validation, and design control processes. Escalate issues when necessary.Navigates challenges that emerge between project execution and policy requirement intent to a compliant outcome.Supports PM to execute validation resource planning and validation support structure.Support the development, manufacture and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers. Assure that the team has policies, processes and procedures in place so that project activities, with regards to design control, process validation and change control, meet applicable quality and regulatory standards, divisional and local requirements.Work closely with the Technical, Engineering, Quality and Research & Development functions in order to ensure changed or new product/processes are implemented in compliance with AN, Corporate and GMP requirements, and in a timely manner to ensure AN business goals are met. Provide visibility and education to the team to ensure proper monitoring and alarming of CPPs through all design phases.Act as a Subject Matter Expert (SME) or represent SME for change, validation and design control processes. Act as a Subject Matter Expert (SME) for application of statistical sampling plans, Design of Experiments (DOE) and design and process failure modes and effects analysis (FMEA). Ensure training requirements are met and that members of the team stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents. Work with the team to understand the root cause of the unexpected outcomes and the impact to approved URS to determine potential solutions that ensure compliance, maintain the integrity of the validation process and enable the team to work towards its goals and objectives.Validation strategy for significant 100+MM and include 1.2B Capital Investments. This individual will make decisions about: overall strategy for validation encompassing all phases and scope of the project/program, external VSP to contract for projects, allocation of effort to internal and external resources, design of experiments (DOE), Statistical Sampling Plans, acceptability of validation results, solutions and way forward when activities do not go as planned.Lead a team of professionals ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct. Develop and maintain validation competency and knowledge within project team.Ensure that quality/compliance issues are highlighted, and Quality decisions are made in a timely manner to facilitate new/changed product supply. Oversee the review and approval of change processes, validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements. Establish service level agreements to ensure timely completion and monitor teams’ performance in support of the site’s validation, design control and on market change projects to ensure best speed to market for new/changed products. Implement site change, validation, and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks. Ensure the expertise and material is available to be able to deploy change, validation, and design control training to the site. Work with corporate, divisional, and capacity expansion teams to ensure the utilization and improvement of consistent, best practice validation and design control policies and procedures. Manage the Validation & Design QA budget to ensure spending is within agreed limits; maintain awareness of financial performance; support the development of cost-efficient business processes whilst ensuring compliance and quality requirements are met.Education: Bachelor's degree3-5 years Validation and Design Control System experience2 years Quality Management experienceApply Now!* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.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 and a Military/Veteran Friendly employer.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.Job SummaryJob number: 31062398Date posted : 2023-07-20Profession: QualityEmployment type: Full time
Source : Abbott