Senior Medical Device Transfer Program Manager

Actalent; Nashville (TN); Hybrid; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

2 weeks PTO + 6 holidays

Hybrid work flexibility

Job summary

Actalent Services is hiring a Senior Project Manager to lead a multi-year manufacturing transfer project within the medical-device industry. You will oversee cross-functional teams to relocate products, processes, and capabilities from an existing facility to alternate internal locations and external partners.

The role requires strategic and execution leadership, collaboration with executive leadership, and ensuring quality, regulatory compliance, and supply continuity across sites.

Qualifications

• Bachelor's degree in Engineering, Operations, Business, Supply Chain, or a related discipline.
• Minimum 8 years of progressive project or program management experience, including responsibility for complex cross-functional initiatives.
• Minimum 5 years of project or program leadership within medical device, life sciences, or another highly regulated manufacturing environment strongly preferred.
• Demonstrated leadership of manufacturing transfers, facility consolidations, insourcing, outsourcing, and/or contract-manufacturing transitions.
• Strong business and financial acumen, including experience evaluating project economics, capital investment, cost structures, total cost, and business cases.
• Exceptional executive-level written, verbal, presentation, and relationship-building skills.
• Advanced project planning, risk management, issue resolution, decision facilitation, and organizational skills.
• Working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation and ISO 13485:2016, plus applicable validation, change-control, and risk-management practices.
• PMP or comparable project/program management certification.

Responsibilities

• Lead evaluation, planning, and execution of large-scale manufacturing process and production transfers across internal sites and external manufacturing partners.
• Develop and compare scenarios including insourcing, outsourcing, contract manufacturing, site consolidation, and transfer to alternate internal facilities.
• Establish decision criteria and evaluate capital requirements, operating costs, capacity, labor availability, technical capability, quality, regulatory requirements, supply risk, timing, and long-term strategic fit.
• Facilitate cross-functional trade-off discussions and convert findings into clear recommendations for leadership approval.
• Maintain business-continuity and supply-risk mitigation as core considerations throughout the transition.
• Partner with Finance and business leadership to build financial models and business cases supporting manufacturing-network decisions.
• Evaluate alternatives using capital investment, operating expense, transition cost, total cost of ownership, unit economics, expected savings, and return measures.
• Track program budgets, forecasts, capital expenditures, financial commitments, savings, and variances throughout execution.
• Serve as the primary program interface with executive leadership.
• Prepare and present executive decision packages, dashboards, milestone reviews, risk assessments, financial implications, and recommendations.
• Lead steering-committee governance and drive timely resolution of decisions, constraints, and escalations.
• Translate complex technical, regulatory, operational, and financial information into concise business language.
• Own the integrated program from feasibility and strategy through detailed planning, transfer, validation, production readiness, stabilization, and closure.
• Manage scope, schedule, budget, resources, dependencies, milestones, assumptions, risks, issues, decisions, and change control.
• Ensure appropriate transfer of equipment, tooling, processes, specifications, work instructions, quality records, manufacturing data, and process knowledge.
• Coordinate process validation, equipment qualification, change control, supplier qualification, manufacturing readiness, and applicable regulatory deliverables.

Skills

Senior Project Management

Manufacturing transfer

Cross-functional leadership

Regulatory compliance

Financial acumen

Executive communication

PMP certification

Education

Bachelor's degree in Engineering/Operations/Business/Supply Chain

Job description

Actalent Services is hiring a Senior Project Manager to lead a multi-year manufacturing transfer project within the medical-device industry. You will oversee cross-functional teams to relocate products, processes, and capabilities from an existing facility to alternate internal locations and external partners.

The role requires strategic and execution leadership, collaboration with executive leadership, and ensuring quality, regulatory compliance, and supply continuity across sites.