Sr Manager, Outsourced Manufacturing
Core
Oversees and executes manufacturing campaigns for Gilead's clinical and commercial oral-solid dosage products within a global external contract manufacturing network, ensuring uninterrupted supply and compliance.
Role type
Senior Manager, Global External Manufacturing (Oral-Solid Dosage)
Builds
Clinical and commercial drug product supply via external CMOs
Domain
Pharmaceutical manufacturing / Contract Manufacturing Organizations (CMO)
Required skills
cGMP compliance, CMO management, technology transfer, supply chain execution, risk management, vendor qualification, contract negotiation, regulatory filing support, change management, continuous improvement
Preferred skills
OSD drug product manufacturing expertise, international regulatory knowledge, cross-functional leadership, complex problem resolution, audit support
Technologies
None explicitly listed
Responsibilities
Define technical requirements for CMO selection, lead CMO management teams, execute inter/intra-company technical transfers, manage CMOs to ensure adherence to Master Production Records, resolve complex technical and compliance issues, provide on-site technical support at CDMO sites, facilitate continuous improvement initiatives, represent GEM on cross-functional product teams, write/review qualification and deviation reports
Seniority
Senior, hands-on IC with strategic oversight