About the Job
The Manager of Supply Chain is responsible for managing the manufacturing of kits used in specimen collection for Laboratory Operations. The role encompasses all specimen collection kit products utilized globally. The incumbent works with contract manufacturers on the kit manufacturing process, ordering, sourcing, logistics, tracking metrics on fulfillment, and quality complaint handling. This role is responsible for kit lifecyle management. The Manager ensures that regulated workflows and change management is adhered to during the kit manufacturing process.
This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.
• Order and/or facilitate the supply of kits to support lab processing.
• Create requisitions for kit inventory based on demand signals and benchmarks set by Associate Director.
• Manage replenishment requests from customer groups like Marketing, Client Services, Clinical Operations.
• Resolve customs related hold for exported kits by working with the courier, FMI, and the recipient site.
• Conduct regular meetings with external contract manufacturers and internal stakeholders to calibrate needs and requirements, and anticipate changes in demands and process.
• Work closely with Procurement to navigate back-order challenges by escalating and communicating to the Supply Chain leadership on plans to alleviate the supply challenge.
• Provide metrics on kit inventory levels, consumption, expiration, and obsolete materials received from kit manufacturers.
• Coordinate and resolve kit logistic complaints with Client Services and other internal stakeholders.
• Gather requirements for new kit products or change requests for existing kits.
• Establish and update existing Bill of Materials for manufactured kits.
• Coordinate with contract manufacturers on kit changes and execute a transition plan that accounts for existing finished goods inventory.
• Communicate change orders using global change management process and implement approved actions.
• Work with suppliers to gather relevant technical certifications and change notification so as to update and align internal FMI Quality documents.
• Author purchasing specifications for the kit product and components.
• Responsible for Non-conformance creation and resolution, implement changes with team to eliminate re-occurrence.
• Work closely with Quality Assurance on customer complaints, Non-conformances, CAPAs, and Supplier Corrective Action Reports.
• Author Temporary Acceptance documentation during change management efforts, such as Temporary Planned Deviations to support material acceptance.
• Adhere to established Facilities SOPs in inventory and health and safety.
• Ensure adherence to Facilities SOPs, GMP / regulated records and work performed accurately and in compliance for GMP, QSR, CLIA and other environments.
• Conduct team meetings discussing kit metrics on a monthly, quarterly, and annual basis to internal and external stakeholders.
• Conduct audits of contract kit manufacturers with Quality Assurance.
• Maintain adherence to environmental and health safety guidelines and policies.
• Maintain a robust and accurate inventory of regulated supplies and assist in generation of reports on consumption.
• Communicate requisition status and delayed shipments to Associate Director.
• Incorporate new inventory materials into existing process workflows.
• Manage return to vendor process from RMA adherence to follow up with Finance.
• Utilize Lean Six Sigma principles and methodologies to minimize waste, reduce costs, and shorten cycle times
• Perform other duties as assigned.
• Bachelor’s degree
• 3+ years of professional experience managing inventories
• 7+ years of experience managing inventories within a life science organization
• APICS or CPIM certification
• Lean Six Sigma Knowledge
• Competency in Inventory and Material Management or similar systems
• Prior Experience:
· Experience in pharmaceutical industry or other GMP regulated industry
· Experience in contract and or internal kit manufacturing
· Experience in quality assurance related documentation such as Planned Temporary Deviations, Non-conformances, and Corrective Action Plans
· Experience in shipping and receiving within good manufacturing practice validated environments
· Experience in working with an enterprise resource planning inventory system
· Experience managing Bill of Materials creation and change independently
• Competent in Microsoft Office and Microsoft Excel
• Demonstrated ability to work independently and cross functionally to influence change
• Demonstrated understanding of business priorities
• Demonstrated ability to work well under pressure while maintaining a professional demeanor
• Collaborative team player with a positive attitude to maintain focus in difficult situations
• Strong problem-solving skills demonstrated through a history of analyzing and developing solutions in coordination with multiple stakeholders
• Strong interpersonal skills that include skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Strong organizational skills and attention to detail
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion
Internal applicants, please use your FMI email address.