Position OverviewThe Quality Systems Manager will oversee and strengthen quality systems to ensure regulatory compliance and continuous improvement across pharmaceutical manufacturing operations.Key ResponsibilitiesManage core quality systems including Deviations, CAPA, Change Control, Training, and Document ControlEnsure ongoing compliance with cGMP and FDA regulations (21 CFR Parts 210 and 211)Lead investigations, root cause analysis, and CAPA effectiveness reviewsSupport regulatory inspections, customer audits, and internal auditsDrive continuous improvement initiatives within the quality management systemQualifications & Experience3–7 years of experience in pharmaceutical quality systems within manufacturing or CDMO environmentsStrong working knowledge of FDA regulations and cGMP standardsExperience with electronic Quality Management Systems (eQMS)Strong stakeholder management, problem-solving, and leadership skills
Job Title
Quality System Manager