Project Manager; Manufacturing Transfer

Job Title: Project Manager - Manufacturing Transfer

Work Arrangement: Onsite

Experience: 12+ years in Project/Program Management, including 5+ years in the Medical Device industry

We are seeking an experienced Project Manager to lead manufacturing and plant transfer initiatives within a regulated medical device environment. The ideal candidate will have a strong background in project governance, manufacturing transfer, contract manufacturing partnerships, quality systems, process validation, and cross-functional stakeholder management.

The successful candidate will be responsible for managing integrated project plans, coordinating product and process transfers, mitigating risks, maintaining continuity of supply, and ensuring projects meet established timelines, quality standards, and business objectives.

• Develop and maintain integrated project plans covering schedules, budgets, milestones, deliverables, resources, and critical path activities.
• Execute manufacturing and plant transfer strategies aligned with the overall contract manufacturing plan.
• Support project governance structures, steering committees, and cross-functional work streams.
• Drive decision-making, issue resolution, and resource allocation across multiple stakeholders.
• Monitor project progress, risks, dependencies, and program-level KPIs.
• Prepare executive presentations, project status reports, and governance meeting materials.
• Facilitate cross-functional meetings to align teams, track milestones, and resolve issues.

• Coordinate the transfer of manufacturing processes, technical documentation, and production activities between sites.
• Ensure continuity of supply throughout the transition and stabilization phases.
• Oversee the transfer of:
• Bills of Materials (BOMs)
• Manufacturing instructions and work instructions
• Process specifications and test methods
• Validation protocols and reports
• Equipment parameters and product history records
• Coordinate pilot builds, engineering builds, and production qualification runs with contract manufacturing partners.
• Facilitate knowledge transfer and ensure receiving-site readiness.

• Ensure compliance with applicable FDA 21 CFR Part 820, ISO 13485, EU MDR, GMP, and customer quality requirements.
• Coordinate Quality Management System (QMS) transfer activities.
• Support validation planning and execution, including:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process validation
• Sterilization validation, where applicable
• Collaborate with Quality, Regulatory, Engineering, and Manufacturing teams to maintain documentation and compliance throughout the transfer.

• Coordinate inventory build strategies to support uninterrupted product supply.
• Manage transfer-related logistics, warehousing, procurement, and distribution activities.
• Collaborate with supply chain teams to identify material availability constraints and mitigate supply risks.

• Coordinate subject matter expert (SME) engagement between originating and receiving manufacturing sites.
• Ensure appropriate training and certification of receiving-site personnel.
• Maintain transfer documentation, training records, lessons learned, and knowledge repositories.
• Manage relationships with contract manufacturing organizations (CMOs) and internal cross-functional teams.
• Facilitate discussions regarding priorities, timelines, resources, and deliverables.

• Identify and assess business continuity, supply chain, regulatory, operational, and capacity risks.
• Develop mitigation strategies, contingency plans, and recovery plans.
• Track project expenditures, cost savings, and transfer-related capital…