We have an opportunity for a Program Manager GxP CAPA Remediation with one of our clients. Please find the job description below.
Job Details
Position: Program Manager GxP CAPA Remediation
Location: Greenville, North Carolina
Work Arrangement: Onsite
Engagement: Contract assignment
Duration: To be confirmed
Start Date: As soon as available
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 onsite 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.