What are the responsibilities and job description for the Program Manager GxP CAPA Remediation position at Kasmo Inc.?
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.