This role leads quality oversight for drug substance development activities at the Upper Merion R&D Pilot Plant ensuring patient safety and regulatory compliance
Job Summary
This role leads quality oversight for drug substance development activities at the Upper Merion R&D Pilot Plant ensuring patient safety and regulatory compliance.
The successful candidate will manage a team of quality professionals while driving systems for change control, deviation management, and CAPA.
GSK offers a culture focused on uniting science, technology, and talent to get ahead of disease together with comprehensive benefits.
Matching Summary
This role leads quality oversight for drug substance development activities at the Upper Merion R&D Pilot Plant ensuring patient safety and regulatory compliance.
Skills & Requirements
Must-have
10+ years in Quality roles
5+ years leading direct reports
Experience with FDA/EMA regulations
cGMP compliance expertise
Inspection readiness management
Supplier and CMO oversight
Nice-to-have
Advanced degree in chemistry or engineering
Experience with fermentation processes
Data-driven decision making skills
Matrix organization experience
Clinical supply release support
Key Requirements
Bachelor's degree in scientific or engineering discipline
10+ years experience in highly regulated Quality roles
5+ years experience in quality management for manufacturing