Senior Clinical Kit Production Lead

ACM Global Laboratories; Horsham (PA); On-site; USD 95,000 - 125,000; Full time

Job summary

Rochester Regional Health in Horsham, PA is seeking a US Kit Production Manager to lead clinical trial kit production and distribution. You will oversee internal operations and external vendors to ensure kits are produced accurately, delivered on time, and compliant with GCP and regulatory requirements.

The role requires strong cross-functional leadership, vendor management, and process improvement skills to support studies, optimize workflow, and drive efficiency and service excellence across

Qualifications

• Bachelor's degree in a quantitative/technical field.
• 3+ years in logistics, supply chain, or clinical kit operations.
• Experience leading teams and managing KPIs.
• Knowledge of GCP/ISO or regulated environments is a plus.
• PMBOK/Lean Six Sigma knowledge is advantageous.

Responsibilities

• Lead daily operations of kit production and distribution.
• Manage internal teams and external vendors with KPIs and SLAs.
• Develop training plans, performance reviews, and coaching.
• Oversee QMS elements, CAPA, and quality events for kitting.
• Collaborate with PMs, CTAs, and supply chain on study readiness.
• Coordinate capacity planning, inventory, and overtime targets.
• Drive lean improvements to reduce waste and cycle times.
• Prepare and manage budgets for staffing and equipment.

Skills

Leadership

Communication

Project management

Problem solving

Lean Six Sigma

GxP knowledge

Education

Bachelor's degree

Master's degree preferred

APICS/CSCP/CPIM a plus

PMP or equivalent

Tools

Microsoft Dynamics

SAP

Inventory/Warehouse mgmt systems

Job description

Rochester Regional Health in Horsham, PA is seeking a US Kit Production Manager to lead clinical trial kit production and distribution. You will oversee internal operations and external vendors to ensure kits are produced accurately, delivered on time, and compliant with GCP and regulatory requirements.

The role requires strong cross-functional leadership, vendor management, and process improvement skills to support studies, optimize workflow, and drive efficiency and service excellence across