Program Manager, GxP CAPA Remediation

At-a-Glance:

Join a leading technology solutions and compliance consulting company as a Program Manager in GxP CAPA Remediation.

Position Type:

• Contract
• On-Site in Greenville, South Carolina

Required:

• Program or workstream management experience in pharmaceutical or regulated life-sciences manufacturing.
• Knowledge of GxP requirements, quality systems, CAPA, and remediation processes.
• Experience coordinating complex, multi-dependency work involving manufacturing, quality, and technical stakeholders.
• Strong facilitation, follow-up, prioritization, written communication, and issue-escalation skills.
• Ability to work on-site and build effective relationships with site teams.

Preferences:

• Experience in specific remediation domains beyond MSAT and validation.
• Experience in CAPA governance, inspection or audit remediation, quality events, or similar initiatives.
• Experience as a consultant or contract program manager at a manufacturing site.

Responsibilities:

• Coordinate CAPA and remediation workstreams from planning to closure, aligning owners, deliverables, and milestones.
• Maintain an integrated view of actions, due dates, dependencies, decisions, and risks across multiple workstreams.
• Facilitate working sessions, follow-up calls, document decisions, and drive ownership and next steps.
• Connect domain teams to manage sequencing and handoffs.
• Escalate overdue actions, emerging risks, and resource conflicts through governance channels.
• Prepare concise status updates for site leaders and stakeholders.
• Support documentation and traceability of remediation progress per site procedures and quality-system expectations.