Third Party Quality Lead
Core
Ensure contracted services and batch documentation meet GMP, regulatory, and client quality requirements for third-party partners.
Role type
Senior IC third-party quality lead (pharmaceutical R&D/manufacturing)
Builds
Quality governance and compliance for external manufacturing partners
Domain
Pharmaceutical manufacturing and R&D
Required skills
cGMP principles, quality agreements, deviation/investigation management, CAPA oversight, third-party audit execution, risk-based decision making, batch disposition/release review, supplier qualification
Preferred skills
API/cell banking oversight, technology transfer support, pharmaceutical R&D lifecycle knowledge, quality performance monitoring
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams)
Responsibilities
Act as primary quality contact for third parties; monitor compliance with GSK standards and cGMP; coordinate quality governance meetings; review and approve quality documentation; assess quality management system records; escalate quality issues; support batch disposition/release; participate in audit planning and execution; support product/process transfers
Seniority
Senior, hands-on IC
