Quality R&d Operations Drug Substance Director

GlaxoSmithKline

Pennsylvania, United States
Quality oversight for drug substance
Cgmp and us regulatory requirements
Inspection readiness and regulatory inspections
Lead quality oversight for drug substance activities in R&D operations at the Upper Merion R&D Pilot Plant

Job Summary

  • Lead quality oversight for drug substance activities in R&D operations at the Upper Merion R&D Pilot Plant.
  • Manage a team of quality and compliance professionals, setting objectives, coaching, and developing people.
  • Drive quality systems and processes for R&D drug substance workstreams, including change control, deviation management, CAPA, and risk assessments.

Matching Summary

Lead quality oversight for drug substance activities in R&D operations at the Upper Merion R&D Pilot Plant.

Skills & Requirements

Must-have

  • Quality oversight for drug substance
  • cGMP and US regulatory requirements
  • Inspection readiness and regulatory inspections
  • Quality systems and processes
  • Supplier and contract manufacturing oversight

Nice-to-have

  • Harnessing smart manufacturing technologies
  • Cross-functional leadership
  • Data-driven decision making
  • Matrix organization experience

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • 10+ years in Quality roles
  • 5+ years in quality management roles
  • 8+ years in pharmaceutical quality/R&D
  • 5+ years leading direct reports
  • Experience with third-party suppliers/CMOs

Work Rights

Not specified

Tailored Resume

Cover Letter