Gmp Compliance Lead

PPD (Thermo Fisher) UK

Ridgefield, NJ, United States
Base: $112,500.00–$168,750.00; bonus/equity: varia...
Hybrid
Gmp-regulated pharmaceutical manufacturing
Inspection readiness and audit facilitation
Aseptic manufacturing and qc laboratory operations
As a GMP Compliance Lead, you will serve as a key leader within the Quality organization, driving inspection readiness and compliance excellence across aseptic manufacturing, quality control laboratories, device/combination products, and packaging operations

Job Summary

  • As a GMP Compliance Lead, you will serve as a key leader within the Quality organization, driving inspection readiness and compliance excellence across aseptic manufacturing, quality control laboratories, device/combination products, and packaging operations.
  • This role offers the opportunity to directly influence product quality, regulatory compliance, and operational excellence while supporting therapies that improve and save lives.
  • Thermo Fisher Scientific offers a comprehensive Total Rewards package including medical, dental, vision benefits effective Day 1, paid time off, retirement savings plans, tuition reimbursement, and an annual incentive plan bonus.

Matching Summary

As a GMP Compliance Lead, you will serve as a key leader within the Quality organization, driving inspection readiness and compliance excellence across aseptic manufacturing, quality control laboratories, device/combination products, and packaging operations.

Salary

Base: $112,500.00–$168,750.00; Bonus/Equity: Variable annual bonus based on performance; Benefits: Comprehensive medical, dental, vision, PTO, retirement plans

Skills & Requirements

Must-have

  • GMP-regulated pharmaceutical manufacturing
  • Inspection readiness and audit facilitation
  • Aseptic manufacturing and QC laboratory operations
  • Electronic quality systems (Trackwise, eDMS, SFLMS)
  • Regulatory compliance with FDA, EMA, MHRA standards
  • CAPA program leadership and root cause analysis

Nice-to-have

  • Cross-functional quality initiative leadership
  • Mentoring and training junior colleagues
  • Strong analytical and risk-based problem solving
  • Clear written and verbal communication
  • Continuous improvement orientation
  • Systems-thinking mindset across manufacturing processes

Key Requirements

  • Bachelor’s degree in Science, Engineering or related discipline
  • Minimum 5+ years GMP pharmaceutical or biologics experience
  • Experience hosting FDA, EMA, and/or MHRA inspections
  • Experience leading CAPA programs and mock inspections
  • Legal authorization to work in the United States
  • Ability to pass background check and drug screening

Work Rights

Must be legally authorized to work in the United States without sponsorship

Tailored Resume

Cover Letter