Associate Manager, Manufacturing Quality Operations

Associate Manager, Manufacturing Quality OperationsLocation: Winston - Salem, NCPosition SummaryThe Associate Manager, Manufacturing Quality Operations serves as the QA lead supporting GMP manufacturing operations within classified production environments. This role provides real-time quality oversight, leads investigations and deviation management activities, and ensures compliance across clinical and commercial manufacturing operations. The position also mentors junior QA staff and partners cross-functionally with Manufacturing, QC, and Facilities teams to support operational excellence and cGMP compliance.Key ResponsibilitiesProvide real-time QA support for manufacturing operations in cleanroom environmentsLead batch record review, deviations, investigations, CAPAs, and issue resolution activitiesSupport line clearance, facility impact assessments, and return-to-service approvalsMake independent quality decisions and escalate critical issues as neededMentor and train junior QA team membersParticipate in audits, inspections, and continuous improvement initiativesMaintain compliance with gowning, safety, and cleanroom proceduresQualificationsBachelor's degree in a scientific discipline or equivalent experience6+ years of QA experience in a GMP-regulated manufacturing environmentMinimum 1 year of people management or leadership experienceAseptic manufacturing experience strongly preferredStrong knowledge of cGMP regulations, quality systems, and manufacturing operationsExcellent analytical, communication, and problem-solving skillsWorking EnvironmentFull-time onsite role in a GMP manufacturing environmentRequires gowning and extended time in cleanroom/classified areasAbility to stand for extended periods and support floor-based operations

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