Global Compliance Manager

Global Compliance Manager

Responsibilities Include:


  • Implement and manage quality systems for the Evansville Technology Center, including HACCP, Allergen control, Foreign Matter control, Processes Quality Control Systems, Pest Control, and other prerequisite programs.

  • Manage interregional Technology Center network to share best practices

  • Responsible for implementation and/or update of above prerequisite programs for all IFCN Global R&D pilot plants.

  • Assure pre-clinical & clinical products and other products for Human Consumption (HC) manufactured at IFCN Global R&D Pilot Plants are in compliance with all applicable Good Manufacturing Practices (GMPs), appropriate domestic/international regulations, and RB quality expectations.

  • Maintain and update Hygiene Zones and Environmental Monitoring program while provide flexibility necessary for Research and Development facilities.

  • Implement batch release program and assure records/documentations, procedures and processes are in compliance with RB standards and applicable regulatory requirements for materials and products for HC produced at IFCN Global R&D Pilot Plants.

  • Lead efforts to improve and maintain Good Manufacturing and Laboratory Practices, validated sanitation procedures, and update as required.

  • Manage change control program for pertinent materials and process changes at EVV Technology Center. Ensure implementation of same change control program at all IFCN Global R&D Pilot Plants.

  • Manage non-conformity program and ensure all non-conformities are properly documented, promptly addressed, and CAPA plans are developed.

  • Coordinate initiatives to assure that processes, procedures and practices in all IFCN Global R&D Pilot Plants are consistent with RB global policy related to food safety.

  • Coordinate internal compliance audits and outside agency audits. Coordinate improvements and mitigation plans.

  • Coordinate / deliver training programs for pilot plant and R&D personnel to maintain MJN GMPs/EHS standard.

  • Lead the Safety Committee and provide direction and implementation of safety practices.

  • Serve as a liaison with local EHS group working closely to drive a safe work environment and implement EHS objectives.

  • Have a general understanding of all processes and demonstrate willingness to take part in production activities, including creating Standard Operating Procedures and work instructions.

  • Contribute to multiple projects and participate in cross-functional project teams to develop and deliver innovation, troubleshooting and/or process optimization.

  • Applies structured problem analysis to provide timely, risk compensated, and data based solutions to product and process issues.
Requirements:

  1. B.S. degree in a Food/Chemical Engineering/Science or related fields with minimum of 7 years' experience leading compliance programs in highly regulated food industry.

  2. Experience with multiple food/diary unit operations including spray drying and/or aseptic processing is required.
  3. Experience interpreting and assuring adherence to GMP, food safety, HACCP, quality systems and regulatory requirements pertinent to a Research and Development facility.
  4. Good understanding of Infant Formula and nutritional products/formulations (powders and liquids), processes, packaging and CIP/Sanitation procedures.
  5. Experience in coordinating/developing and implementing standards operating procedures and training programs.
  6. Experience working with corporate compliance organization and external regulatory agencies. PLM( Product Lifecycle Management)/ SAP (Systems, Applications & Products) / EHS (Environmental Health & Safety) experience is a must
  7. Ability to be a self-starter and minimally managed. Excellent interpersonal skills and strong communication skills, both verbal and written.
  8. Ability to work well in a fast paced, multi-task environment under pressure and tight time constraints where a high degree of teamwork, flexibility, and collaboration are required.

Must be able to work effectively with all levels of personnel in a global R&D matrix organization

Working Environment


  1. Combination of office, pilot plant, and production environments


Travel


  1. 20-25% international travel is required.



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