GSK is seeking a Quality R&D Operations Drug Substance Director to oversee quality compliance in drug substance activities at their Upper Merion R&D Pilot Plant. The ideal candidate will have extensive experience in pharmaceutical quality and regulatory environments, focusing on patient safety and effective process management
Job Summary
Lead quality oversight for drug substance activities in R&D operations at the Upper Merion R&D Pilot Plant.
Drive quality systems and processes for R&D drug substance workstreams, including change control, deviation management, CAPA, and risk assessments.
Partner with cross-functional teams to enable product development milestones and timely release of clinical materials.
Matching Summary
Match Score: 85
GSK is seeking a Quality R&D Operations Drug Substance Director to oversee quality compliance in drug substance activities at their Upper Merion R&D Pilot Plant. The ideal candidate will have extensive experience in pharmaceutical quality and regulatory environments, focusing on patient safety and effective process management.
Skills & Requirements
Must-have
quality oversight drug substance
cGMP and US regulatory requirements
inspection readiness and regulatory inspections
supplier and contract manufacturing oversight
clinical material release
Nice-to-have
drug substance development processes
quality systems implementation
data-driven decision making
matrix organization experience
Key Requirements
Bachelor's degree in scientific or engineering discipline
10+ years in Quality roles in regulated environment
5+ years in quality management roles for manufacturing operations