The role requires leading integrated Master Transfer Plans spanning sending and receiving sites to ensure long-term corporate success
Job Summary
The role requires leading integrated Master Transfer Plans spanning sending and receiving sites to ensure long-term corporate success.
Candidates must drive operational readiness including cleanroom setup, equipment installation, and workforce onboarding while maintaining strict quality standards.
Success is measured by completing product transfers within budget, achieving zero major non-conformances during audits, and ensuring effective stakeholder communication.
Matching Summary
The role requires leading integrated Master Transfer Plans spanning sending and receiving sites to ensure long-term corporate success.
Skills & Requirements
Must-have
8-10 years project management experience
Medical device manufacturing environment
Product and process transfer leadership
ISO 13485 and FDA 21 CFR 820 compliance
Equipment validation IQ OQ PQ protocols
Master Transfer Plan development and execution
Nice-to-have
PMP or Prince2 certification preferred
Lean Six Sigma credentials
Strong coaching and conflict resolution skills
Experience with EU/US logistics and import clearance
Ability to travel up to 60% internationally
Key Requirements
Bachelor's degree in engineering or Project Management
Minimum 8-10 years of experience in medical device manufacturing
Proven track record managing NPI to production transfers
Strong knowledge of GMP, EHS, and regulatory compliance