Program Manager - GxP CAPA Remediation

PQE- Program Manager - GxP CAPA Remediation

Location: Greenville, SC

Work Arrangement: 100% Onsite, Monday-Friday

Duration: 6 Months

We are looking for an experienced Program Manager with a strong pharmaceutical manufacturing and quality background to support a site-based CAPA remediation program in Greenville, SC.

This role will focus on coordinating multiple remediation workstreams, driving action items to closure, tracking dependencies, and working closely with Manufacturing, Quality, Validation, MSAT, and other site functions. This is a hands-on GxP program management role and is not intended for an IT-focused Project Manager.

Key Responsibilities

• Coordinate CAPA and remediation activities across multiple site workstreams from planning through closure.
• Track milestones, action items, owners, due dates, dependencies, risks, and open decisions.
• Facilitate working sessions with cross-functional teams and ensure clear ownership and timely follow-up.
• Work closely with Manufacturing, Quality, Validation, MSAT, Engineering, and other technical teams to keep remediation activities moving.
• Identify delays, risks, resource conflicts, and cross-functional dependencies and escalate when required.
• Prepare concise status updates, action trackers, and progress summaries for site and program leadership.
• Support documentation and traceability of remediation activities in accordance with applicable GxP and quality-system requirements.
• Drive follow-up and closure of assigned actions while maintaining alignment with site priorities and remediation timelines.
  
  

Qualifications

• Strong program, project, or workstream management experience within pharmaceutical, biotechnology, or regulated life-sciences manufacturing.
• Prior experience supporting CAPA remediation, inspection readiness, audit remediation, quality-system improvement, or similar site-level programs.
• Experience working as a consultant or program manager within a pharmaceutical manufacturing site.
• Good understanding of GxP quality systems, CAPA, remediation, deviations, and regulated manufacturing operations.
• Experience managing complex cross-functional activities involving Manufacturing, Quality, Validation, Engineering, or technical operations.
• Strong facilitation, communication, documentation, prioritization, and follow-up skills.
• Ability to work independently, identify risks early, and drive teams toward timely closure of actions.