Compliance Manager - Sturgis MI Plant (31030969)
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 113,000 colleagues serve people in more than 160 countries.
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. Abbott’s Nutrition Division 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 ABBOTT
At 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 yr 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%
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: [Register to View]
Implement quality standards, ensure and execute compliance on every stage of the process.
What You’ll Work On
The Compliance Manager designs and implements new and revised quality functions to sustain the changing business. Manages all plant areas to comply to GMP’s, FDA regulations and other practices outlined by federal statues or other regulatory agencies. Minimizes potential for business interruptions due to regulatory interference. Liaison for the plant during FDA, Corporate and other external audits. Manage all internal and external audits. Assesses plant operations against FDA actions taken at other facilities within Abbott and at other sites in comparable industries. Develops preventive actions plans for identified areas of risk. Provides regular, scheduled appraisals of site compliance to local and division management. Liaison with Division Compliance Assurance to assure communication of all compliance issues. Develops and maintains site compliance training programs. Assists with training of employees as appropriate. Serves as the local expert resource in response to plant compliance training needs. Assures hazard analysis is conducted for all existing and new plant systems.
Responsible for implementing and maintaining the effectiveness of the quality system.
Liaison for the plant during FDA, Corporate and other external audits, working directly with the QA Director. Responsible for escorting FDA and other regulatory agencies through the plant during inspections. Review plant positions with the FDA, Rabbinical visits, Corporate Quality Assurance and other regulatory agencies. Provide corrective actions and feedback, where appropriate. Manage all Audits, including FDA, Corporate and other external Audits. Directly responsible for coordinating the audits.
Develop and manage annual audit plans. Audits include conducting procedural audits, manual review audits, cGMP audits, audits required by the Infant Formula regulations, and other miscellaneous audits.
Work with all plant departments and division personnel to establish and assure completion of all audit observations and commitments.
Assure all plant areas comply with current Good Manufacturing Practices as outlined by federal statutes.
Perform cGMP audits and walk through of all plant areas.
Assess regulations on a routine basis to ensure the plant meets the requirements of the regulations or practices.
Assess 483 observations from Abbott and other manufacturing operations similar to Abbott and determine plant vulnerability to similar observations.
Develop preventative action recommendations and implement. Develop cGMP training program for all employees and any additional training that may be related to Quality Systems and issues.
Assess new Corporate and Division policies for potential impact on plant operations and make recommendations for implementation. Once policies are implemented, develop plant procedure, and then monitor changes to establish plant compliance status against the new policy.
Audit ECA’s, validation packages, maintenance work orders and other related document that may be subject to FDA and/or Corporate audits.
Provide regular reviews of site compliance status with plant management staff. Manage the Quality Engineering group.
Serve as liaison to the Plant Staff as follows:
Provide recommendations for entire plant compliance in order to minimize audit and product liability.
Manage FDA initiated customer complaints.
Manage in-plant execution of the plant’s audit program.
Develop and issue quality reports related to quality or regulatory issues.
Direct Reports - 1-5 salary exempts
Education and Experience You'll Bring:
Bachelor's Degree in a Business, Scienece or Technical area or equivalent work experience; Engineering or Food Science Preferred.
4 years knowledge of food processing techniques, federal and state regulations, documentation requirements and statistical applications is essential.
Two years supervisory/leadership required.
This position must have good technical background and a thorough understanding of Low Acid Food regulations, Infant formula regulations, kosher and Halal laws, Corporate and Division policies, plant procedures and other governmental regulations affecting the manufacturing and distribution of product produced at the plant.
The Plant QA Compliance/Services Manager must be both aggressive and creative in solving problems to avoid significant production downtime and/or product losses or recalls.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: [Register to View]
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.