Our client is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. With 113,000 colleagues, they serve people in more than 160 countries. They seek a Director of Global Microbiology & Food Safety in their Midwest location. The role has the broad objective of providing functional and strategic leadership for global microbiological, food safety and sterilization services for all their nutrition global functions, including all manufacturing facilities, pilot plants, third party manufacturers and allied operations (e.g., Third Party Laboratories).
- Lead and manage a global team of technical experts responsible for critical elements of Company’s quality and food safety systems.
- Define global strategies to create, optimize and maintain industry leading microbiological & food safety culture and systems ensuring the quality and safety of all products.
- Initiate and lead complex global programs driving risk mitigation strategies and process improvements.
- Ensure adequate staffing and leadership continuity through talent management, succession planning and developmental moves to establish and maintain an industry leading quality & food safety system, ensuring compliance with all applicable internal and external regulations and assuring the safety of Company’s products. Foster an inclusive organization and encourage diversity within the organization.
- Establish Global Microbiological and Food Safety Policies & Standards and ensure consistent roll-out and implementation across global network (scope includes environmental monitoring, micro testing of ingredients, products intermediates & finished products, sterilization, and heat treatment processes)
- Share responsibility for all aspects of Quality and Regulatory Compliance necessary to ensure that there is no major disruption of business due to quality or compliance issues.
- Hold primary responsibility for successful design, implementation and execution of strategic microbiological initiatives and programs across the global network.
- Provide scientifically sound guidance and direction for product disposition and management of complex microbiological challenges and investigations
- Proactively engage with regulatory agencies across all regions. Ensure timely filing and approval of new (sterilization) processes. Maintain detailed understanding of the global regulatory landscape and emerging microorganisms of concern.
- Provide leadership to Company plants and third-party manufacturers assuring manufacturing processes and environments are microbiologically safe for producing both new and existing products.
- Advise Sr. Leadership, including Division Vice President of Quality Assurance on high impact/risk events such as product quality, safety, and regulatory issues.
- Optimize organizational efficiency and manage cost through Operational Excellence, implementation of new technologies, knowledge transfer among sites / regions and Business Excellence tools.
- Maintain knowledge of innovative microbiology and relationships with industry and external testing laboratories, while keeping informed of the current regulatory environment through such means as professional organizations and corporate memberships.
- Proactively partner with R&D and Engineering in developing and commercializing new products and innovative technologies across global network.
- Effectively collaborates across all operational, technical, and commercial functions at all levels including Third Party Manufacturers (TPM), and other outsourcing organizations to assure product performance and efficacy requirements are fulfilled in Company products.
- Provide expertise and direction on laboratory and functional testing methods and regimes.
- Responsible for coordination of internal and external microbiology testing to ensure accuracy of data and timely communication of results.
- Share responsibility for sterilization and heat treatment programs at Company manufacturing sites and TPM’s, including oversight to microbiological design and validation of critical process steps (manages “process authority” role within Company).
- Share responsibility for the design and execution of microbiology and sanitation training for manufacturing and other supply chain functions.
- Use internal and external resources to design microbiology-related studies for understanding and managing product and process development risks.
- Provide influential leadership with US and OUS sites in driving proactive quality and food safety improvements and harmonization
- Engages with external partners including regulators (e.g., US FDA), KOL’s and Industry Groups
B.S. in related field of study required
Master’s or Doctorate Degree in Science/ Microbiology preferred
10 years of experience in Microbiology and/or Food Science & Safety.
Management experience with minimum of 5 years of supervisory experience.
Broad experience in food microbiology (e.g., environmental control, aseptic techniques, culturing techniques, identifying different classes of microorganisms, microbial spoilage, etc.)
Experience in designing industrial microbiological standards and control programs (HACCP, Food Safety plans)
Experience with the manufacturing and control of powdered infant formula
Experience with aseptic processing and sterilization processes
Knowledge of microbiology, good laboratory practices, safety controls, manufacturing processes, sanitary design, Good Manufacturing Practices, auditing, troubleshooting, and microbiological test procedures.
Demonstrated ability to evaluate microbiologically sensitive business risks.
Effective oral and written communication skills and ability to appropriately communicate sensitive information in a timely manner.
Ability to design and execute testing to manage safety risks for new and existing products and technologies.
Ability to effectively interact with and manage suppliers, consultants, regulatory agencies, and other external partners.
Up to 25% travel required.
Ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making.
Ability to summarize and present technical recommendations and solutions to senior management.
As an employee, you’ll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program
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.
For more information, please contact Moira McGrath at OPUS International, Inc. at (954) 428-3888 or email@example.com