Program Manager GxP CAPA Remediation

Hiring: Program Manager – GxP CAPA Remediation

Location: Greenville, NC
Work Arrangement: Onsite
We are looking for an experienced Program Manager – GxP CAPA Remediation to lead and coordinate complex CAPA and quality remediation initiatives within a pharmaceutical / life sciences manufacturing environment.

Key Responsibilities:

• Lead and coordinate CAPA and quality remediation workstreams from initiation through closure.

• Manage milestones, deliverables, dependencies, risks, issues, and action items.

• Coordinate cross-functional teams across Manufacturing, Quality, Validation, MSAT, and Engineering.

• Drive timely completion of remediation actions and escalate delays or risks.

• Support CAPA governance, audit remediation, and regulatory inspection remediation.

• Prepare leadership-level status reports and maintain documentation traceability.

• Ensure remediation activities align with GxP and Quality Management System requirements.

Required Qualifications:

• 10+ years of Program / Project / Workstream Management experience in Pharma, Biotech, Medical Device, or regulated Life Sciences manufacturing.

• 5+ years of GxP/GMP and Quality Management System experience.

• 5+ years of practical CAPA and quality remediation experience.

• Experience managing audit findings, regulatory observations, and inspection remediation.

• Strong experience coordinating Manufacturing, Quality, Validation, MSAT, and Engineering stakeholders.

• Excellent governance, risk management, stakeholder coordination, and reporting skills.

• Must be willing to work onsite in Greenville, NC.

Important: This is a Pharma Quality / CAPA Remediation Program Management role, NOT an IT Project Management position.