Senior Director, Global Supply Chain & Device Manufacturing

About The Job

The Sr Director, Global Supply Chain & Device Manufacturing leads a global team of employees across the United States and Germany to ensure best in class operational performance end to end. This position develops, recommends, and implements a sustainable Supply Chain and Device Manufacturing strategy in alignment with FMI’s corporate strategy to support all FMI laboratories as well as current and future user sites in Asia and Europe. The Sr Director collaborates with Procurement, Quality, Regulatory, Site Directors, and Lab Operations in setting objectives and is responsible for setting investment priorities, strategic workforce planning, maintaining subject matter expertise and defining and implementing projects and capabilities within the FMI organization in support of the corporate initiatives. An essential part of this role is to develop a sustainable outsourcing strategy for device manufacturing,

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Provide the strategic direction and leadership required for achieving the objectives of the supply chain and device manufacturing operation to deliver towards FMI’s vision in compliance with regulatory, company policies and all applicable regulatory and safety requirements.
• Provide a broad, innovative and compelling vision to continuously improve quality and provide cost-effective services for the future of end-to-end Supply Chain including Lean Manufacturing; champion transformational change using Operational Excellence methodology, and act as a catalyst of change/stimulate others to embrace and pave the way for change.
• Oversee extensive end to end supply chain of critical reagents, consumables and raw materials; set goals and lead activities to ensure effective use of resources across all sites; control expenses to achieve maximum productivity and to meet product quality standards and supply plans within planned budget.
• Collaborate with Procurement to maintain role clarity, embrace planner/buyer role and delegate supplier relationship management to Procurement.
• Provide technical expertise to act as a bridge between Procurement, PD, and Innovation in Operations to identify alternative suppliers and design for lower COGS and redundancy from early stages of product development.
• Manage all operational aspects of FMI’s domestic and international specimen kit program.
• Manage all operational aspects of FMI’s internal reagent kitting program.
• Lead the Reagent QC team to maintain and improve incoming material QC processes towards lowering COGS, TAT, and inventory levels. Innovative thinking and deep understanding of various regulatory requirements is required to make a step change versus current processes.
• Develop and aggressively pursue an outsourcing strategy for device manufacturing that allows FMI to reduce complexity and facilitates expansion with more tech transfer sites globally.
• Manage Lab Asset Management of all Corrective, Preventive Maintenance, Calibrations etc. on Lab Equipment (this includes R&D assets). This includes management of Service Contracts. Close alignment with Tech Ops is required to eliminate duplication of activities.
• Develop and administer budgets, schedules and performance requirements for department; implement metrics to track and lead successful, timely accomplishment of assigned objectives.
• Design, develop, implement and ensure adherence to compliance, which includes improvements to current programs and ensuring staff members are trained on programs.
• Participate in incident investigations and CAPAs; lead when assigned.
• Assess existing processes and systems for efficiency and scalability, working with Process Excellence to make improvements and streamline operations of the team.
• Define and secure appropriate global inventory levels and alternative suppliers for all direct and indirect materials in close collaboration with Procurement to avoid stock-outs.
• Plan supply and inventory capacity, and therefore timely material distribution, between global laboratories and Coverage Days of Inventory (CDI).
• Be responsible for distribution of specimen collection kits to all sales regions, manufacturing (kitting) of materials that constitute critical parts of the various medical devices, and QC supply and release of materials to the clinical and R&D laboratories.
• Ensure all activities are documented and performed to IVDR and other regulatory standards.
• In collaboration with Procurement, Quality, Regulatory, Lab Directors, and Lab Operations, set objectives and investment priorities, be responsible for strategic workforce planning, maintain subject matter expertise and define and implement projects and capabilities within the FMI organization in support of the corporate initiatives.
• Provide leadership and continuously develop, inspire and empower a diverse staff; lead all aspects of team talent management, including performance, career development, and succession planning.
• Recruit, retain and develop a high-performing and diverse team of employees.
• Create a climate that fosters and encourages collaboration and teamwork.
• Monitor compliance with safety regulations, ensuring adequate training is provided for staff; coordinate planning/execution of standardized operating procedures across sub-teams and sub-contractors.
• Interface effectively with global network and partner with Site Heads and functional leads to achieve maximum efficiencies through interdepartmental coordination.
• Build and maintain strong relationships with Roche Diagnostics and potential other outsourcing partners for device manufacturing,
• Chair FMI Material Review Board.
• Chair S&OP Process Team.
• Contribute as member of Operations Leadership team.
• Other duties as assigned.
  
  

Qualifications

Basic Qualifications

• Bachelor’s Degree in Supply Chain, Engineering, Scientific or related field; AND
• 12+ years of regulated industry related experience in Global Supply Chain and/or Manufacturing/Lab Operations
• 5+ years of management/leadership experience
  
  

Preferred Qualifications

• Master's Degree in related field
• APICS Certification
• 5+ years of experience in managing a diagnostic kit manufacturing operation
• Previous experience leading end to end supply chain in clinical, diagnostic or pharmaceutical supply chain management, including R&D support and validation shipping protocols
• Significant experience in global scale, regulated reagent-manufacturing, QC and distribution, including QSR Design Control and cGMP
• Proficient knowledge and experience with cGMP, GDP, and GCP standards and guidance documents such as Annex 13 and IVDR
• Experience with business processes and management in IVDR manufacturing environments
• Experience in defining or at least deploying an ERP system
• Experience working in a technical applications/support role
• Evidence of exceptional program management skills deployed across multiple, diverse projects with multiple high impact interdependencies
• Proficiency in developing cost and production models for manufacturing teams
• Ability to deliver results on schedule in a fast-paced, dynamic environment
• Detail oriented with excellent prioritization and organizational skills
• Strong skillset in collaborating cross-functionally in a complex and matrixed environment
• Excellent analytical and problem-solving skills
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion