The role requires leading integrated Master Transfer Plans spanning sending and receiving sites with a focus on minimal disruption and excellent quality assurance
Job Summary
The role requires leading integrated Master Transfer Plans spanning sending and receiving sites with a focus on minimal disruption and excellent quality assurance.
Candidates must ensure all transfer deliverables satisfy strict ISO 13485 and FDA 21 CFR 820 regulatory requirements while driving operational readiness.
Success is measured by completing product transfers within agreed timelines, achieving zero major non-conformances during audits, and meeting cost-saving targets.
Matching Summary
The role requires leading integrated Master Transfer Plans spanning sending and receiving sites with a focus on minimal disruption and excellent quality assurance.
Skills & Requirements
Must-have
8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
ISO 13485 and FDA 21 CFR 820 compliance
Process validation URS IQ OQ PQ protocols
Cross-functional stakeholder management
Nice-to-have
Lean Six Sigma credentials
PMP or Prince2 certification
Strong coaching abilities
International travel up to 60%
Conflict resolution skills
Key Requirements
Bachelor's degree in engineering or Project Management