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