Program Manager – GxP CAPA Remediation

Job Description
We are seeking an experienced Program Manager to lead Corrective and Preventive Action (CAPA) remediation initiatives within a regulated pharmaceutical or biotech manufacturing environment. The ideal candidate will have strong knowledge of GxP regulations, FDA audit remediation, quality systems, and Lean Six Sigma methodologies.

This is a business and quality-domain program management role, not an IT project management position.

Key Responsibilities
Lead CAPA and GxP remediation activities from planning through closure.

Manage remediation plans, milestones, deliverables, risks, and dependencies.

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

Facilitate stakeholder meetings and drive action-item completion.

Monitor remediation progress and escalate delays, risks, and resource constraints.

Prepare program status reports and leadership updates.

Ensure documentation, traceability, and closure evidence meet GxP and quality system requirements.

Support FDA audit/inspection remediation and CAPA governance activities.

Required Qualifications
10+ years of program/project management experience.

Strong pharmaceutical, biotech, or regulated manufacturing domain experience.

Hands-on knowledge of GxP, CAPA, and quality management systems.

Experience supporting FDA audits, inspections, or remediation initiatives.

Knowledge of Lean Six Sigma methodologies.

Strong stakeholder management, communication, and issue-resolution skills.

Ability to work on-site in Greenville, with remote candidates considered if approved.

Preferred Qualifications
Experience managing audit and inspection remediation programs.

Consulting or contract program management experience in regulated manufacturing.

Relevant Lean Six Sigma certification.

Mandatory Skills
GxP

CAPA

FDA Audit/Inspection Remediation

Lean Six Sigma

Program Management