Mandatory Skills
- 12+ years of Program/Project Management experience
- 5+ years of medical device industry experience
- Manufacturing, plant, product, or process transfer; CMO/contract manufacturer coordination
- FDA 21 CFR Part 820, ISO 13485, GMP, QMS transfer
- IQ/OQ/PQ, process validation, risk, schedule, resource, and budget management
- Cross-functional/stakeholder leadership and Microsoft Project or equivalent tools
Job Description
Key Responsibilities
Project Leadership & Governance
Maintain a 'single source of truth' for overall project plans – including schedules, budgets, milestones, tasks, and deliverables – ensuring alignment across all teams.
Develop and manage integrated project plans, milestones, and critical path activities.
Execute the overall plant transfer strategy and roadmap inline with the CM plan.
Support Project Head with establishing governance structure, steering committees, and cross-functional workstreams.
Drive decision-making and issue resolution across multiple stakeholders.
Provide guidance and direction to project team members as necessary, assisting in clearing barriers to progress.
Resolve resource issues and facilitate reallocation of activities and efforts to ensure schedules are achieved.
Support Project Head in providing regular updates on program status, challenges, and risks to functional leadership and senior management.
Support Project Head in facilitating regular cross-functional core team meetings to align on program goals, track progress, and address any issues or risks promptly
Support Project Head in preparing materials for the STC, PRC and other cross-functional meeting by co-ordinating with core team members
Collect, maintain, and monitor program-level KPIs dashboard to identify potential issues early and drive continuous improvement in delivery
Manufacturing Transfer Management
Coordinate transfer of manufacturing processes and technical documentation.
Ensure continuity of supply during transition and stabilization phase.
Product & Process Transfer
Ensure complete transfer of:
Bills of Materials (BOM)
Manufacturing Instructions
Process Specifications
Test Methods
Validation Protocols
Equipment Parameters
Product History Records
Coordinate with CM- pilot builds, engineering builds, and production qualification runs.
Quality & Regulatory Compliance
Ensure compliance with:
FDA 21 CFR Part 820
EU MDR
ISO 13485
GMP requirements
Customer quality requirements
Facilitate Quality Management System (QMS) transfer activities.
Manage validation strategy in discussion with internal team including:
IQ
OQ
PQ
Process Validation
Cleaning Validation
Sterilization Validation (where applicable)
Supply Chain & Procurement
Ensure inventory build strategy supports uninterrupted supply to customers.
Coordinate transfer of logistics, warehousing, and distribution activities.
Knowledge Transfer
Coordinate Subject Matter Expert (SME) engagement between OEM and CMO.
Ensure training and certification of receiving-site personnel.
Establish documentation and lessons-learned repository.
Risk Management
Identify program risks and develop mitigation strategies.
Conduct risk assessments including:
Business Continuity Risks
Supply Risks
Regulatory Risks
Operational Risks
Capacity Risks
Develop contingency and recovery plans.
Stakeholder Management
Manage relationships with:
Contract Manufacturing Organization
Internal functions
Facilitate governance meetings and executive communication.
Facilitate negotiation of priorities, timelines, and resource requirements.
Financial Management
Track project expenditures and savings.
Monitor transfer-related capital investments.
Required Qualifications
Experience
12+ years of experience in Program Management.
5+ years experience in the medical device industry, preferably with sterile disposable medical devices.
Technical Expertise
Lean Manufacturing
Six Sigma
Quality Systems
Critical Competencies
Leadership
Stakeholder management
Cross-functional leadership
Program Management
PMP or equivalent preferred
Schedule management
Resource planning
Strong experience with Microsoft Project or other Project Management software.
Risk management
Communication
Executive presentations
Influencing without authority
Analytical
Problem solving
Data-driven decision-making
Financial analysis
Root cause investigation
Success Metrics (KPIs)
Project Delivery
Transfer completed on schedule
Achievement of milestone dates