Program Manager – GxP CAPA Remediation

Job Title: Program Manager – GxP CAPA Remediation
Location: Greenville, SC (On-site)
Job Type: Contract
Duration: To be confirmed based on remediation scope
Start Date: ASAP

Job Description

We are seeking an experienced Program Manager – GxP CAPA Remediation to lead the coordination and execution tracking of CAPA remediation workstreams within a regulated pharmaceutical manufacturing environment.

This is a domain-focused program management position requiring strong knowledge of GxP, CAPA processes, and quality-system environments. The selected candidate will work on-site with Manufacturing, Quality, Validation, MSAT, and other functional teams to drive remediation activities, manage dependencies, track commitments, and ensure timely closure.

Key Responsibilities

• Coordinate CAPA and remediation workstreams from initial planning through closure.

• Maintain integrated remediation trackers covering actions, owners, due dates, dependencies, milestones, and risks.

• Facilitate cross-functional meetings, working sessions, decision-making, and follow-up activities.

• Coordinate work sequencing and handoffs across Manufacturing, Quality, Validation, MSAT, and related teams.

• Identify and escalate overdue actions, risks, blockers, and resource conflicts.

• Prepare clear and concise status reports, progress updates, and escalation summaries for site leadership.

• Support documentation, traceability, and quality-system expectations.

• Monitor remediation progress and drive accountability across all participating teams.

Required Qualifications

• Demonstrated program or workstream management experience in pharmaceutical manufacturing or regulated life sciences.

• Strong understanding of GxP requirements, CAPA processes, and pharmaceutical quality systems.

• Experience coordinating complex remediation initiatives involving multiple functions and dependencies.

• Strong stakeholder management, meeting facilitation, prioritization, and escalation skills.

• Excellent organizational, documentation, communication, and follow-through skills.

• Willingness and ability to work on-site in Greenville, South Carolina.

Preferred Qualifications

• Experience with CAPA governance, audit findings, inspection readiness, or quality-event remediation.

• Experience supporting remediation initiatives beyond MSAT or validation alone.

• Consulting or contract program management experience embedded within pharmaceutical manufacturing sites.

• Experience coordinating quality, manufacturing, validation, and compliance stakeholders.

Important Candidate Requirements

This position is not an IT Program Manager role. Candidates must demonstrate relevant pharmaceutical or regulated life sciences experience, including GxP and CAPA remediation knowledge.

Candidates with only software development, cloud, infrastructure, or general IT project management experience without relevant GxP/CAPA experience are unlikely to be suitable.

Work Location: Greenville, SC – On-site
Engagement: Contract
Start: Immediate

Interested candidates should submit an updated resume highlighting their GxP, CAPA remediation, pharmaceutical manufacturing, and quality-system experience.