Quality R&d Operations Drug Substance Director

GSK

Upper Merion, Pennsylvania, United States
Not specified; not specified; comprehensive benefi...
Not specified (assumed hybrid or onsite based on role requirements)
10+ years quality role experience
5+ years manufacturing operations management
8+ years pharmaceutical r&d quality
GSK is seeking a Quality R&D Operations Drug Substance Director to lead quality oversight in drug substance activities at their Upper Merion R&D Pilot Plant. The ideal candidate will have extensive experience in quality roles within regulated environments, strong leadership skills, and a focus on compliance and patient safety

Job Summary

  • This role leads quality oversight for drug substance development activities at the Upper Merion R&D Pilot Plant to ensure patient safety and regulatory compliance.
  • The successful candidate will manage a team of quality professionals while driving systems for change control, deviation management, and risk assessments.
  • GSK offers a culture focused on uniting science and technology to deliver complex medicines and vaccines efficiently to patients globally.

Matching Summary

Match Score: 85

GSK is seeking a Quality R&D Operations Drug Substance Director to lead quality oversight in drug substance activities at their Upper Merion R&D Pilot Plant. The ideal candidate will have extensive experience in quality roles within regulated environments, strong leadership skills, and a focus on compliance and patient safety.

Salary

Not specified; Not specified; Comprehensive benefits program available

Skills & Requirements

Must-have

  • 10+ years Quality role experience
  • 5+ years manufacturing operations management
  • 8+ years pharmaceutical R&D quality
  • cGMP and FDA regulatory compliance
  • Inspection readiness and regulatory response
  • Team leadership and coaching skills
  • Third-party supplier oversight

Nice-to-have

  • Advanced degree in chemistry or engineering
  • Experience with fermentation and synthesis
  • Data-driven decision making capabilities
  • Matrix organization partnership experience
  • Clinical supply release support
  • Process improvement track record

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • 10+ years in regulated Quality roles
  • 5+ years leading direct reports
  • Prior experience with FDA/EMA/MHRA inspections
  • US work authorization required

Work Rights

Not specified

Tailored Resume

Cover Letter