Program Manager, GxP CAPA Remediation

Greenville, South Carolina  |  On-site  |   Duration: To be confirmed

Role summary  Lead coordination and execution tracking for site-level corrective and preventive action (CAPA) remediation workstreams in a regulated pharmaceutical manufacturing environment. This is a domain-focused program management role for a complex, interdependent portfolio of remediation activities. The manager will work on site with manufacturing, quality, and other functional owners to keep actions moving, surface dependencies and risks, and maintain clear, timely follow-through. This is not an IT project management position.

Key responsibilities

·   Coordinate assigned CAPA and remediation workstreams from planning through closure, aligning accountable owners, deliverables, milestones, and evidence expectations.

·   Maintain an integrated view of actions, due dates, dependencies, decisions, and risks across multiple site workstreams; identify slippage and resolve blockers with the appropriate owners.

·   Convene and facilitate working sessions, make timely follow-up calls, document decisions, and drive clear ownership and next steps after each discussion.

·   Connect manufacturing, quality, validation, MSAT, and other relevant domain teams so that sequencing and handoffs are understood and managed.

·   Escalate overdue actions, emerging risks, resource conflicts, and cross-functional dependencies through agreed governance channels.

·   Prepare concise, accurate status updates and action records for site leaders and program stakeholders, including progress, exceptions, and decisions required.

·   Support disciplined documentation and traceability of remediation progress in accordance with site procedures and applicable quality-system expectations.

Required qualifications

·   Demonstrated program or workstream management experience in pharmaceutical manufacturing or another regulated life-sciences manufacturing setting.

·   Working knowledge of GxP requirements and the quality-system environment, including CAPA and remediation processes.

·   Experience coordinating complex, multi-dependency work involving manufacturing, quality, and technical or operational stakeholders.

·   Strong facilitation, follow-up, prioritization, written communication, and issue-escalation skills; able to make calls and drive actions to closure.

·   Ability and willingness to work on site in Greenville, South Carolina, and build effective working relationships with site teams.

Preferred qualifications

·   Experience with the specific remediation domain(s) assigned to the workstream; domain expertise beyond MSAT and validation is to be confirmed.

·   Experience supporting CAPA governance, inspection or audit remediation, quality events, or comparable regulated change initiatives.

·   Experience working as a consultant or contract program manager embedded with a manufacturing site.

Assignment details

Location and work arrangement: Greenville site, on-site preferred.  Engagement: Contract/partner resource.  Start: As soon as available.  Duration: To be confirmed based on remediation scope and workstream needs.