Jobs → Engineering → Program Manager - GxP CAPA

Program Manager - GxP CAPA

American IT SystemsUnited StatesMIDPosted 25m ago
GXPCAPAFDA AuditLean – Six SigmaProgram ManagementPharmaceuticalQuality SystemsStakeholder ManagementCross-functional Coordination
About the Role We are seeking an experienced Program Manager to lead CAPA remediation workstreams in a regulated pharmaceutical manufacturing environment. This role will drive cross-functional coordination, track remediation progress, manage risks and dependencies, and ensure timely closure of corrective and preventive actions. Key Responsibilities • Manage CAPA and remediation activities from planning through closure • Track actions, milestones, risks, dependencies, and deliverables • Facilitate cross-functional meetings and drive action-item completion • Coordinate with Manufacturing, Quality, Validation, MSAT, and other site teams • Escalate risks, delays, and resource constraints • Prepare status reports and updates for leadership and stakeholders • Ensure documentation and remediation traceability align with GxP and quality system requirements Requirements • Experience managing programs/projects in pharmaceutical, biotech, or other regulated manufacturing environments • Strong knowledge of GxP, CAPA, and quality systems • Proven ability to manage complex, cross-functional remediation initiatives • Excellent stakeholder management, communication, and issue-resolution skills • Ability to work on-site in Greenville, SC Preferred Experience • Experience with audit/inspection remediation and CAPA governance • Consulting or contract program management experience in manufacturing environments

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