Senior Manager, Inspection Management

Moderna

Remote
Base: $130,800.00 - $209,400.00; bonus/equity: eli...
Fully remote
Gcp, gvp, glp regulatory authority inspections
Inspection readiness and preparation activities
Develop responses to inspection findings
Moderna is seeking a Senior Manager of Inspection Management to oversee regulatory inspections, ensuring compliance with health authority regulations. This remote position requires strong collaboration with R&D teams and expertise in regulatory processes within the biotech or pharmaceutical sectors

Job Summary

  • Focus on Regulatory Health Authority inspection planning, logistics, and supporting inspections, ensuring compliance with Health Authority Regulations.
  • Responsible for conducting Regulatory Authority pre-inspection, during inspection and post-inspection activities across R&D.
  • Contribute to the ongoing operations of the R&D Quality Regulatory Intelligence Program in issuance of multi-discipline monthly briefing reports to the organization.

Matching Summary

Match Score: 85

Moderna is seeking a Senior Manager of Inspection Management to oversee regulatory inspections, ensuring compliance with health authority regulations. This remote position requires strong collaboration with R&D teams and expertise in regulatory processes within the biotech or pharmaceutical sectors.

Salary

Base: $130,800.00 - $209,400.00; Bonus/Equity: Eligible for annual discretionary bonus, other incentive compensation, or equity award; Benefits: Best-in-class healthcare coverage, holistic well-being resources, family planning benefits, generous paid time off

Skills & Requirements

Must-have

  • GCP, GVP, GLP regulatory authority inspections
  • Inspection readiness and preparation activities
  • Develop responses to inspection findings
  • Track corrective and preventative actions
  • Lead post-inspection lessons learned sessions

Nice-to-have

  • Foster a quality culture
  • Regulatory intelligence activities
  • Collaborate with industry benchmarking
  • Contribute to issue management program

Key Requirements

  • BS/BA, MS or PhD and 10, 8, 6 years experience
  • Knowledge of FDA, EU, ICH GCP guidelines
  • Experience with inspection coordination
  • Experience developing responses to findings
  • Ability to work independently and in team

Work Rights

U.S. persons only

Tailored Resume

Cover Letter