Sr Dir Quality

Endogastricsolutions

St. Louis, Missouri, United States
Primarily office-based with occasional manufacturing area visits and 10-15% travel
15 years pharmaceutical industry experience
Cgmp compliance and regulatory standards
Quality systems management including capa
Endogastric Solutions is seeking a Senior Director of Quality to oversee quality functions at their St. Louis plant, ensuring compliance with cGMP and regulatory standards while leading quality assurance teams. The ideal candidate will possess extensive experience in the pharmaceutical industry, particularly in quality assurance and regulatory affairs, with strong leadership and communication skills

Job Summary

  • The Sr. Director, Quality is responsible for ensuring cGMP compliance and product quality at the Saint Louis facility while supporting broader site quality initiatives.
  • This role provides strategic leadership in the development and oversight of site quality systems to ensure all manufacturing activities meet regulatory standards.
  • The position involves managing Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business.

Matching Summary

Match Score: 85

Endogastric Solutions is seeking a Senior Director of Quality to oversee quality functions at their St. Louis plant, ensuring compliance with cGMP and regulatory standards while leading quality assurance teams. The ideal candidate will possess extensive experience in the pharmaceutical industry, particularly in quality assurance and regulatory affairs, with strong leadership and communication skills.

Skills & Requirements

Must-have

  • 15 years pharmaceutical industry experience
  • cGMP compliance and regulatory standards
  • Quality Systems management including CAPA
  • Leadership of QA and QC teams
  • FDA and international regulatory inspections

Nice-to-have

  • Experience with Generics Business
  • Cost minimization strategies
  • Continuous improvement culture
  • Strong negotiation skills
  • Patient and customer focus

Key Requirements

  • Bachelor's degree in chemistry, microbiology, or life sciences
  • Minimum 15 years of pharmaceutical industry experience
  • Minimum 5 years managerial experience in quality/regulatory affairs
  • Experience with bulk drug substances and solid dosage forms

Work Rights

Not specified

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