Global Compliance Manager
- Evansville, IN
Global Compliance Manager
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.
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.
Experience with multiple food/diary unit operations including spray drying and/or aseptic processing is required.
- Experience interpreting and assuring adherence to GMP, food safety, HACCP, quality systems and regulatory requirements pertinent to a Research and Development facility.
- Good understanding of Infant Formula and nutritional products/formulations (powders and liquids), processes, packaging and CIP/Sanitation procedures.
- Experience in coordinating/developing and implementing standards operating procedures and training programs.
- 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
- Ability to be a self-starter and minimally managed. Excellent interpersonal skills and strong communication skills, both verbal and written.
- 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
Combination of office, pilot plant, and production environments
20-25% international travel is required.
Back to top