Program Manager

985fm.ca

Penang, Malaysia
Integrated master transfer plan
Product transfer & ramp-up
Equipment de-install, crating/shipping
Build and manage an integrated Master Transfer Plan spanning sending and receiving sites, running phase gates from readiness, validation, launch, and stabilization

Job Summary

  • Build and manage an integrated Master Transfer Plan spanning sending and receiving sites, running phase gates from readiness, validation, launch, and stabilization.
  • Lead process transfer activities from sending sites to the receiving site, ensuring minimal disruption and excellent quality assurance.
  • Ensure transfer deliverables satisfy ISO 13485 and FDA 21 CFR 820 requirements and drive process/equipment validation strategy.

Matching Summary

Build and manage an integrated Master Transfer Plan spanning sending and receiving sites, running phase gates from readiness, validation, launch, and stabilization.

Skills & Requirements

Must-have

  • Integrated Master Transfer Plan
  • Product Transfer & Ramp-Up
  • Equipment de-install, crating/shipping
  • IQ/OQ/PQ protocols
  • GMP, EHS, and regulatory compliance
  • Cross-functional leadership

Nice-to-have

  • Customer success focus
  • Innovation and collaboration
  • Respectful interaction
  • Open and honest communication
  • Doing the right things

Key Requirements

  • Bachelor’s degree in engineering, Project Management, or related field
  • 8–10 years of experience in project management
  • Medical device manufacturing environment experience
  • Proficiency with PM tools (e.g., MS Project, Smartsheet)
  • PMP/Prince2 or equivalent preferred
  • Lean/Six Sigma credentials preferred
  • International travel up to 60%

Work Rights

Not specified

Tailored Resume

Cover Letter