US Kit Production Manager

Rochester Regional Health

1d • $95,000 - $125,000 • Onsite

About The Position

The US Kit Production Manager leads clinical trial kit production and distribution, overseeing both internal operations and third-party vendors. The role ensures kits are produced accurately, delivered on time, and comply with study protocols, GCP, and regulatory requirements. The manager works cross-functionally with project management, supply chain, laboratory operations, and external partners to support clinical studies and drive operational efficiency and service excellence.

Requirements

• Bachelor’s degree required, preferably in Business, Operations/Supply Chain Management, Engineering, Statistics, or a related quantitative/technical field.
• Minimum 3+ years of experience in logistics, supply chain, central laboratory, clinical trial operations, or related kitting/production environment.
• 3 years' experience in a lead, supervisory, or managerial role.

Nice To Haves

• Master's Degree preferred in Business, Supply Chain or another quantitative field
• Experience working within GCP, ISO, or other regulated environments preferred.
• Demonstrated experience in clinical trial logistics, central lab operations, or medical device/clinical supply kitting, including exposure to outsourced provider management.
• Strong people's leadership skills with a track record of building, developing, and motivating operational teams.
• Proven ability to manage KPIs, daily management systems, and data-driven performance improvement.
• Excellent organizational skills with the ability to manage competing priorities, and deadlines in a fast-paced environment.
• Strong attention to detail and commitment to quality, compliance, and patient safety.
• Effective written and verbal communication skills, with the ability to interface clearly with PMs, CTAs, laboratory staff, vendors, and external partners.
• Analytical mindset with the ability to use data, metrics, and problem-solving tools to drive performance and continuous improvement.
• APICS/ASCM certifications such as CPIM (Certified in Planning and Inventory Management) or CSCP (Certified Supply Chain Professional) a plus.
• Project Management Professional (PMP) or equivalent project management certification a plus.
• Proficiency with standard office and ERP/logistics systems (e.g., Microsoft Dynamics, SAP, or general inventory/warehouse management systems); experience with performance dashboards and KPI reporting tools is a plus.
• Lean Six Sigma Green Belt or Black Belt, or certification in lean production/operations management or similar continuous improvement methodologies preferred.

Responsibilities

• Maintain daily departmental performance by managing resources, prioritizing tasks, and developing and monitoring metrics.
• Oversee daily management of the team to effectively handle day-to-day workload.
• Hire, coach and develop direct reports, including definition of role and responsibilities, training, development and performance management.
• Facilitate communication as a point of escalation or strategic point of contact for the department.
• Identify, lead, and/or participate in cross-functional process improvement initiatives to optimize operational capabilities.
• Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education.
• Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance.
• Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans.
• Foster professional development through continuous coaching and performance management.
• Own daily management of Quality Events within the internal/external kitting department, including logging, investigation, root cause analysis, corrective and preventive actions (CAPA), and timely closure.
• Provide department-level oversight and ownership of the Quality Management System (QMS) elements relevant to kitting (SOPs, work instructions, change control, training records, and documentation).
• Ensure robust QC processes for kit build, labeling, documentation, and dispatch; provide hands-on support with QC checking when required.
• Ensure kitting processes are executed in accordance with approved study protocols and laboratory instructions, Good Clinical Practice (GCP) guidelines, applicable US clinical trial regulations and statutory requirements, company Health and Safety policies and Human Resources policies & internal SOPs and quality standards.
• Participate in internal and external audits and inspections, provide necessary documentation, and implement audit findings and recommendations within the department.
• Oversee the preparation and build of clinical specimen collection kits per laboratory protocol, PM/Client instructions, and study-specific requirements.
• Ensure consistency of output and documentation between printing technicians and kit build technicians.
• Collaborate with Stock/Materials Management to maintain appropriate inventory levels of kit components, supporting minimum safety stocks and uninterrupted production.
• Lead the stand-up of new or additional kit production lines, facilities, or operational cells as study volumes grow or business needs change, including: Defining layout, flow, and staffing models. Supporting equipment and system implementation. Developing SOPs, training, and qualification plans.
• Coordinate special kit requests, urgent builds, and expedited shipments to investigator sites using appropriate courier services.
• Ensure sample kits are produced and available for new, upcoming, and amended studies, including pilot and validation kits as needed.
• Partner with Logistics/Supply Chain leadership to manage department overtime, temporary labor, and productivity targets; implement actions to reduce unnecessary overtime and improve efficiency.
• Contribute to departmental budget planning by providing input on staffing, materials, equipment, and outsourced service costs.
• Lead or support lean and continuous improvement projects focused on workflow optimization, error reduction, turnaround time improvement, and cost efficiency, applying structured methods such as Lean Six Sigma as applicable.
• Manage outsourced (third-party) kitting provider(s) to ensure adequate throughput, service levels, and daily/monthly volume as required for ACM. Establish and maintain clear SLAs, KPIs, and performance dashboards for external kitting partners; conduct regular business reviews and performance evaluations.
• Coordinate forecast and demand signals to providers, ensuring capacity, material availability, and readiness for new or expanded studies. Address performance issues, quality events, and process gaps with external providers, driving corrective actions, and continuous improvement.
• Serve as the primary operational point of contact for kitting-related queries from PMs, CTAs, Laboratory Operations, and Supply Chain.
• Communicate daily issues, risks, and resolutions related to orders, timelines, kit specifications, and vendor performance.
• Coordinate effectively with Production, PMs, CTAs, Laboratory staff, and external partners to ensure clear, timely information flow and alignment on study priorities. Represent the kitting function in cross-functional meetings, providing input into study start-up, feasibility, and operational readiness activities.

Benefits

• Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager