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Program Manager GxP CAPA Remediation

Kasmo Inc.

Hybrid in Greenville, North Carolina • 3d ago

Easy Apply

Third Party, Contract

Depends on Experience

GxP Systems and Support Administrator

CAI

Remote • Today

Full-time

USD 130,000.00 - 150,000.00 per year

Technical Project Manager - SaMD / GxP Validation

Medasource

Remote • Today

Contract

$60.00 - $80.00

Program Manager

ITCON Services

Remote • 15d ago

Easy Apply

Full-time

150,000 - 180,000

Job Details

Skills

GxP/GMP
CAPA
Stakeholder
Risk Management
Remediation

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91008812
Position Id: 9133197
Posted 3 days ago

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Contact the job poster

Jabiulla Vazeer

Recruiter @ Kasmo Inc.

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Job Details

Skills

GxP/GMP
CAPA
Stakeholder
Risk Management
Remediation

Summary

Hiring: Program Manager – GxP CAPA Remediation

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.