Program Manager - GxP CAPA Remediation

Role: Program Manager - GxP CAPA Remediation

Location: Greenville, SC (Hybrid)

Duration: 12+ Months

Mandatory areas:

• Program Manager: 10+ years

• Must Have skills:

• GXP, CAPA, FDA Audit, Lean – Six Sigma

About the role:

• Seeking an experienced Program Manager to lead CAPA remediation workstreams in a regulated pharmaceutical manufacturing environment.

• This role will drive cross-functional coordination, track remediation progress, manage risks and dependencies, and ensure timely closure of corrective and preventive actions. This is a business/domain-focused role and not an IT project management position.

Responsibilities:

• Manage CAPA and remediation activities from planning through closure. Track actions, milestones, risks, dependencies, and deliverables.

• Facilitate cross-functional meetings and drive action-item completion.

• Coordinate with Manufacturing, Quality, Validation, MSAT, and other site teams.

• Escalate risks, delays, and resource constraints.

• Prepare status reports and updates for leadership and stakeholders.

• Ensure documentation and remediation traceability align with GxP and quality system requirements.

Requirements:

• Experience managing programs/projects in pharmaceutical, biotech, or other regulated manufacturing environments.

• Strong knowledge of GxP, CAPA, and quality systems.

• Proven ability to manage complex, cross-functional remediation initiatives.

• Excellent stakeholder management, communication, and issue-resolution skills.

In compliance with the salary transparency law, the expected pay range for this role is $60/hr. Actual compensation depends on experience and interview evaluation