Senior GxP CAPA Remediation Program Manager

Cynet Systems•Greenville, NC
•Onsite

About The Position

Seeking an experienced Program Manager to lead CAPA remediation workstreams in a regulated pharmaceutical manufacturing environment. This business- and domain-focused role will drive cross-functional coordination, track remediation progress, manage risks and dependencies, and ensure timely closure of corrective and preventive actions. It is not an IT project management position. The role requires on-site work in Greenville, Client.

Requirements

  • Experience managing programs or 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.
  • Ability to work on-site in Greenville, Client.

Nice To Haves

  • Experience with audit or inspection remediation and CAPA governance.
  • Consulting or contract program management experience in manufacturing environments.

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.
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