Job Description

Position Overview

The Quality Systems Manager will oversee and strengthen quality systems to ensure regulatory compliance and continuous improvement across pharmaceutical manufacturing operations.


Key Responsibilities

  • Manage core quality systems including Deviations, CAPA, Change Control, Training, and Document Control
  • Ensure ongoing compliance with cGMP and FDA regulations (21 CFR Parts 210 and 211)
  • Lead investigations, root cause analysis, and CAPA effectiveness reviews
  • Support regulatory inspections, customer audits, and internal audits
  • Drive continuous improvement initiatives within the quality management system


Qualifications & Experience

  • 3–7 years of experience in pharmaceutical quality systems within manufacturing or CDMO environments
  • Strong working knowledge of FDA regulations and cGMP standards
  • Experience with electronic Quality Management Systems (eQMS)
  • Strong stakeholder management, problem-solving, and leadership skills

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