Abbott Compliance and Food Safety Manager - Sturgis, MI Plant in Sturgis, Michigan

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Job Summary:

  • Designs and implements new and revised quality functions to sustain the changing business

  • Manage all plant areas to comply to GMP’s, FDA regulations and other practices outlined by federal statues or other regulatory agencies

  • Minimize 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

  • Assess plant operations against FDA enforcement actions taken at other facilities within Abbott and at other sites in comparable industries. Develop preventive action plans for identified areas of risk

  • Provide regular, scheduled appraisals of site compliance to local and division management

  • Liaison with Division Compliance Assurance to assure communication of all compliance issues

  • Develop and maintain site compliance training programs; assist with training of employees as appropriate and serve as the local expert resource in response to plant compliance training needs

  • Assure hazard analysis is conducted for all existing and new plant systems

Main Responsibilities:

  • 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 Manager

  • Responsible for escorting FDA and other regulatory agencies through the plant during inspections

  • Defend plant positions to 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 documents 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 and 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 and Develop and issue quality reports related to quality or regulatory issues.

The Quality Assurance Compliance Manager assures that all documents and operations in the plant are in compliance with the standards established by Abbott, Abbott Nutrition and other regulatory agencies. Failure to uphold these standards could result in product recall, loss of market share and/or consumer endangerment. The Quality Assurance Compliance Manager is responsible for managing plant performance to key audit commitments, either through Corporate or other external audits or FDA 483 observations. Failure to meet these commitments may result in major business interruptions due to FDA concerns or observations. Many of these key commitments are goals held by Divisional Vice Presidents and Managers.

The incumbent’s scope of authority encompasses:

Act on the part of the Plant Quality Assurance Manager during his/her absence; direct communication with FDA or outside agencies in the QA Manager’s absence; determination of what procedures/policies meets past/present 483 or audit commitments; make decisions on issues affecting proper cGMP and documentation practices; setting plant standards regarding current Good Manufacturing Practices and managing the Plant Auditing program and developing additional Plant Systems to ensure compliance with quality related issues.

Education:

Bachelors Degree required, technical area preferred plus 5-7 years of relevant experience in Quality Assurance and/or Manufacturing. Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com