Program Manager with GxP CAPA-Greenville,NC[Onsite]

OMG Technology • North Carolina, NC

2d • Onsite

About The Position

The Program Manager – GxP CAPA Remediation coordinates assigned CAPA and remediation workstreams from planning through closure. The role aligns accountable owners, deliverables, milestones, and evidence expectations, and maintains an integrated view of actions, due dates, dependencies, decisions, and risks across multiple site workstreams. The Program Manager identifies slippage, resolves blockers with appropriate owners, and escalates overdue actions, emerging risks, resource conflicts, and cross-functional dependencies through agreed governance channels.

The position convenes and facilitates working sessions, follows up with stakeholders, documents decisions, and drives clear ownership and next steps. It connects manufacturing, quality, validation, MSAT, and other relevant teams to manage sequencing and handoffs. The role also prepares concise, accurate status updates and action records for site leaders and program stakeholders, and supports disciplined documentation and traceability of remediation progress in accordance with site procedures and applicable quality-system expectations.

This is an onsite contract assignment in Greenville, North Carolina. The duration is to be confirmed, and the start date is as soon as available.

Requirements

• 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; ability to make calls and drive actions to closure.
• Ability and willingness to work onsite in Greenville and build effective working relationships with site teams.

Nice To Haves

• 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.

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 appropriate owners.
• Convene and facilitate working sessions, make timely follow-up calls, document decisions, and drive clear ownership and next steps.
• Connect manufacturing, quality, validation, MSAT, and other relevant domain teams to manage sequencing and handoffs.
• 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.

What This Job Offers

• Career Level: Mid Level
• Education Level: No Education Listed