Job Title: Manager, US Kit Production
Department: Logistics
Location: Onsite, Horsham, PA
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday
Position Summary:
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.
Key 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…