Sr. Manager, Gxp Compliance Officer

479

Remote, US
Base: $140,000-$165,000; bonus/equity: target 14% ...
Fully remote
Us-fda regulatory compliance expertise
Cgmp and cglp knowledge
Global manufacturing site oversight
The Sr. Manager, GxP Compliance Officer at Fresenius Kabi oversees compliance with US-FDA regulations across global manufacturing and R&D sites. The role requires extensive experience in pharmaceutical compliance and offers a competitive salary and benefits package

Job Summary

  • The Sr. Manager, Gxp Compliance Officer ensures all manufacturing sites and R&D Centers comply with US-FDA regulations including cGMPs and electronic records.
  • This role involves leading global compliance activities, managing investigations, and preparing facilities for upcoming US-FDA inspections through training and mock audits.
  • The position offers a competitive salary range of $140,000-$165,000 with a target bonus of 14% and comprehensive benefits including 401(k) contributions and health coverage.

Matching Summary

Match Score: 85

The Sr. Manager, GxP Compliance Officer at Fresenius Kabi oversees compliance with US-FDA regulations across global manufacturing and R&D sites. The role requires extensive experience in pharmaceutical compliance and offers a competitive salary and benefits package.

Salary

Base: $140,000-$165,000; Bonus/Equity: Target 14% of base salary; Benefits: 401(k) with company contribution, medical, dental, vision, paid vacation

Skills & Requirements

Must-have

  • US-FDA regulatory compliance expertise
  • cGMP and cGLP knowledge
  • Global manufacturing site oversight
  • FDA inspection preparation and support
  • Root cause analysis and investigation management

Nice-to-have

  • Established contacts to US-FDA
  • Experience with Mutual Recognition agreements
  • Strategic optimization of quality processes
  • Leadership in cross-functional working groups

Key Requirements

  • Minimum Bachelor's degree required
  • 8+ years pharmaceutical industry experience
  • Thorough knowledge of aseptic and sterilized manufacturing processes
  • Proven experience leading GxP audits or inspections

Work Rights

Not specified

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