Associate Director, Analytical R&d/ar&d

Catalent

Winchester, KY, US
Fda ich usp ep jp mhra compliance
Analytical method validation and transfers
Oos/oot investigation and root cause analysis
Develop and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage

Job Summary

  • Develop and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage.
  • Oversee the Analytical R&D team for method development, transfers, and validations processes to support new product pipelines.
  • Ensure all Quality Control systems remain compliant with current FDA, ICH, USP, EP, JP, and MHRA regulations while managing OOS investigations.

Matching Summary

Develop and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage.

Skills & Requirements

Must-have

  • FDA ICH USP EP JP MHRA compliance
  • Analytical method validation and transfers
  • OOS/OOT investigation and root cause analysis
  • CAPA implementation and quality systems
  • CFR Part 11 data integrity adherence
  • DEA controlled substances handling SOPs
  • Laboratory instrument IQ/OQ calibration

Nice-to-have

  • Strategic vision for competitive advantage
  • Cross-functional partnership with formulation
  • Experience with FDA regulatory inspections
  • Employee training program development
  • Stability testing program oversight

Key Requirements

  • Bachelor's degree in Chemistry or Related Field
  • 8 years of experience in job offered or related occupation
  • Experience as Analytical Chemist or equivalent duties

Work Rights

Not specified

Tailored Resume

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