Quality System Manager

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 systemQualifications & 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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