Senior Project Manager

Actalent; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Actalent is seeking a Sr. Project Manager, Manufacturing Network & Process Transfer to lead cross-functional relocations of medical-device products and processes.

You will partner with executive leaders across Operations, Engineering, Quality, Regulatory, Supply Chain, and Finance to evaluate options, build business cases, and execute transfers. Responsibilities include defining strategies, managing scope and budgets, ensuring regulatory compliance, and delivering transfers with minimal

Qualifications

• Bachelor's degree in Engineering, Operations, Business, Supply Chain, or a related discipline.
• 8+ years of progressive project or program management experience, including responsibility for complex cross-functional initiatives.
• 5+ years of project or program leadership within medical device, life sciences, or another highly regulated manufacturing environment strongly preferred.

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.

Skills

Leadership

Cross-functional collaboration

Executive communication

Strategic planning

Risk management

Travel readiness

Education

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

PMP certification

Tools

Financial modeling tools

Job description

The Sr. Project Manager, Manufacturing Network & Process Transfer, leads complex cross-functional initiatives involving the relocation of medical-device products, processes, equipment, and manufacturing capabilities from an existing facility to alternate internal locations and/or external manufacturing partners. The role operates at both strategic and execution levels, helping the organization determine the appropriate manufacturing model and then leading delivery of the approved path.

This individual partners with executive leadership and functional leaders across Operations, Engineering, Quality, Regulatory Affairs, Supply Chain, Procurement, Finance, and external providers to evaluate options, build business cases, secure decisions, and execute the transfer without unacceptable disruption to product quality, regulatory compliance, customer service, or continuity of supply.

Required Qualifications

• Bachelor's degree in Engineering, Operations, Business, Supply Chain, or a related discipline.
• 8+ years of progressive project or program management experience, including responsibility for complex cross-functional initiatives.
• 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.
• Ability to travel to manufacturing sites and external partners as program needs require.

Preferred Qualifications

• PMP or comparable project/program management certification.
• Experience with supplier selection, contract manufacturers, supplier quality, procurement, or make-versus-buy decisions.
• Experience supporting acquisition integration, site closure, network optimization, or manufacturing-footprint transformation.
• Experience with executive steering committees and enterprise PMO governance.
• Engineering or manufacturing operations background within medical devices.

Role Scope & Decision Expectations

• Operate independently with minimal supervision within approved governance.
• Define problems, structure alternatives, test assumptions, and recommend decisions in situations where information may be incomplete or competing priorities exist.
• Escalate issues with an impact assessment, alternatives, and a recommended path, not merely a status description.
• Balance cost, speed, capacity, compliance, quality, service, and long-term strategic value.
• Maintain objective documentation of key decisions, assumptions, owners, and approval authorities.

Key Responsibilities

Strategic Manufacturing & Network Optimization

• 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 appropriate to the decision.
• Lead scenario and sensitivity analysis to test the impact of changes in volume, labor, yield, logistics, timing, investment, and operational assumptions.
• Track program budgets, forecasts, capital expenditures, financial commitments, savings, and variances throughout execution.
• Escalate material changes to assumptions or economics and recommend corrective action or reconsideration of the approved path.
• Serve as the primary program interface with senior and 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.
• Influence stakeholders and establish accountability across a matrixed organization without direct authority.

Program & Transfer Execution

• 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.
• Coordinate deliverables across Manufacturing, Engineering, Quality, Regulatory, R&D, Supply Chain, Procurement, Finance, IT, facilities, and external providers as applicable.
• Identify critical-path activities, resource constraints, and interdependencies; establish mitigation and recovery plans.
• Create a disciplined transition to operational ownership with acceptance criteria and post-transfer performance monitoring.

Quality, Regulatory & Manufacturing Readiness

• 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.
• Integrate quality and regulatory requirements into planning, decisions, risk management, and executive reporting.
• Partner with Quality and Engineering to confirm that receiving sites or providers can repeatedly meet approved product and process requirements.
• Ensure outsourced transitions include effective technical transfer, quality agreements, governance, performance expectations, and escalation mechanisms.