Senior Manager, FDA Compliance

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Senior Manager, FDA Compliance

Join the Global Remediation Team as a Senior Manager of FDA Compliance for a International Pharmaceutical Company!


This is a remote position with 50% travel (domestic and international).


Key Responsibilities:

  • Lead and oversee global remediation efforts across manufacturing and R&D sites.
  • Identify and mitigate plant quality and compliance risks.
  • Prepare manufacturing sites and R&D centers for US-FDA inspections.
  • Drive strategic optimization of cGMP and quality processes.
  • Develop and deliver need-based compliance training programs.


Key Requirements:

  • 8+ years' experience in pharmaceuticals and US-FDA compliance.
  • Advanced degree in science or engineering (highly desirable).
  • Comprehensive knowledge of cGMPs, ICH guidelines, and drug transfer processes.
  • Proven ability to lead and motivate teams towards innovative solutions.
  • Excellent communication and project management skills.


Ready to make a lasting impact on patient safety and product quality?


Apply for Senior Manager, FDA Compliance

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