Quality Change Control Specialist

Position OverviewWe are seeking a Change Control Specialist to support regulated pharmaceutical manufacturing operations by managing change control activities in compliance with cGMP and global regulatory standards. The role will partner closely with Quality, Manufacturing, Validation, and Engineering teams to ensure changes are assessed, implemented, and closed effectively.Key ResponsibilitiesManage the complete change control lifecycle, including initiation, impact assessment, approval, implementation, and closureConduct cross-functional impact assessments across quality, manufacturing, validation, and regulatory areasEnsure compliance with cGMP requirements and FDA regulations, including 21 CFR Parts 210 and 211Maintain accurate and inspection-ready documentation within electronic quality systemsSupport internal, customer, and regulatory audits related to change managementQualifications & Experience3–7 years of experience in pharmaceutical manufacturing or CDMO environmentsHands-on experience managing change controls within regulated quality systemsWorking knowledge of cGMP and FDA 21 CFR 210/211 regulationsExperience with electronic QMS platforms such as TrackWise, Veeva, or equivalentStrong documentation, coordination, and compliance orientation

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