Quality Management System Specialist

Job Summary

A company is looking for a QMS Senior Specialist.

Key Responsibilities

• Lead global governance, harmonization, and continuous improvement of QMS processes aligned with regulatory expectations
• Co-develop and manage global inspection readiness programs, including audits and inspection support
• Oversee raw material and supplier quality programs, including audits and compliance assessments

Required Qualifications and Education

• 7-10+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance in relevant environments
• Direct QMS experience within Drug Product manufacturing
• Strong expertise in QMS frameworks and regulatory standards (GMP, GxP, ISO, HACCP)
• Bachelor's degree in a scientific or technical discipline required; advanced degree preferred
• Lean/Six Sigma certification is a plus