Dir, Project Management
Core
Lead global project management for late-stage pipeline programs and commercial product lifecycle, specifically focusing on establishing and maintaining robust local testing programs for biologics and vaccines in China.
Role type
Senior Project Management Director (Regulatory & Quality Operations)
Builds
Commercial product extensions and uninterrupted supply of biologics and vaccines in China
Domain
Biopharmaceuticals (Large Molecules, Vaccines, Biologics) / Regulatory Affairs / Quality Control
Deliverable
client delivery
Required skills
Project Management, Analytical Method Development, Biochemistry, GMP Laboratory, Risk Management, Cross-Functional Leadership, Regulatory Compendia Knowledge, Troubleshooting, Logistics Coordination
Preferred skills
Large molecule method validation, Deviation management, LIMS, Software automation (Veeva Vault, MEDs)
Technologies
Veeva Vault, MEDs, LIMS
Responsibilities
Establish professional relationships with Chinese government and contract testing laboratories; Support establishment of test methods and provide troubleshooting; Facilitate logistics for reagent and sample shipments; Lead cross-functional teams for product licensure; Influence development of regulatory compendia chapters; Author regulatory and technical documentation.
Seniority
Director, strategic leadership & execution
