External Site Lead, Global External Manufacturing
Core
Overseeing partnerships with Contract Development and Manufacturing Organizations (CDMOs) to ensure seamless manufacturing operations for pharmaceutical and biologics assembly and packaging.
Role type
Senior management lead for external manufacturing operations
Builds
High-quality manufacturing operations and supply chain delivery for biologics and pharmaceuticals
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
CDMO relationship management, assembly and packaging technical expertise, change control management, process performance qualification, regulatory compliance (cGMP, FDA/EMA), supplier contract negotiation, business performance review, project management, data analysis
Preferred skills
Engineering background, cross-functional leadership, conflict resolution, continuous improvement strategy
Technologies
None explicitly listed
Responsibilities
Manage and oversee CDMO relationships with a focus on manufacturing execution; Provide technical and operational oversight for assembly, label and pack; Manage global change controls and deviations; Drive technology transfers; Author and review site-specific Continuous Process Verification (CPV) reports; Develop and implement corrective actions; Lead continuous improvement initiatives; Manage supplier relationship activities from contract negotiation to execution; Conduct business performance reviews and manage partner governance
Seniority
Management level, strategic oversight and team leadership