Sr Manager, Gxp Compliance Officer

479

Base: $172,000-$180,000; bonus: target 14% of base...
Fully remote
8+ years us-fda compliance experience
Knowledge of cgmps and cglps regulations
Experience with aseptic and lyophilized manufacturing
The Sr. Manager, GxP Compliance Officer position at Fresenius Kabi involves ensuring compliance with US-FDA regulations across manufacturing and R&D sites. The role requires extensive experience in the pharmaceutical industry, particularly in compliance and quality management, along with a strong analytical background

Job Summary

  • The Sr. Manager ensures all manufacturing sites and R&D centers comply with US-FDA regulations including cGMPs and electronic records.
  • This role involves leading preparation for upcoming US-FDA inspections, performing mock inspections, and supporting response to FDA-483 observations.
  • The position offers a salary range of $172,000-$180,000 with a target bonus of 14% and comprehensive benefits including 401(k) matching.

Matching Summary

Match Score: 85

The Sr. Manager, GxP Compliance Officer position at Fresenius Kabi involves ensuring compliance with US-FDA regulations across manufacturing and R&D sites. The role requires extensive experience in the pharmaceutical industry, particularly in compliance and quality management, along with a strong analytical background.

Salary

Base: $172,000-$180,000; Bonus: Target 14% of base salary; Benefits: 401(k) with company contributions, medical, dental, vision

Skills & Requirements

Must-have

  • 8+ years US-FDA compliance experience
  • Knowledge of cGMPs and cGLPs regulations
  • Experience with aseptic and lyophilized manufacturing
  • Leading global compliance activities and teams
  • Conducting mock inspections and FDA-483 responses

Nice-to-have

  • Established contacts to US-FDA
  • Previous experience managing GxP audits
  • Strong analytical problem-solving skills
  • Ability to work in ambiguous situations
  • Project management in Quality Management Systems

Key Requirements

  • Minimum Bachelor's degree required
  • Advanced degree in chemistry or biology highly desirable
  • Must be authorized to work for any employer in the United States
  • No visa sponsorship available
  • 8+ years practical experience in pharmaceutical industry

Work Rights

Must be authorized to work for ANY employer in the United States

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