CAPA Compliance & Audit Coordinator - Pharma/Biotech/Life Sciences

Location: Whippany, NJ – Onsite contract – 12‑month initial term with extension potential – Global scope, GxP‑regulated environment.

Position Overview

Support a global pharmaceutical organization’s Medical Affairs function by managing CAPAs, supporting compliance initiatives, and coordinating audits/inspections within a GxP‑regulated environment. Ideal for a compliance/quality professional with 3‑5 years of pharma experience – no scientific background required.

Key Responsibilities

• Coordinate CAPAs from initiation through closure.
• Support audits, inspections, and audit‑readiness activities.
• Track findings, commitments, and corrective actions to completion.
• Monitor compliance risks and identify process improvements.
• Support issue management and investigations.
• Prepare compliance reports and status updates.
• Partner cross‑functionally to ensure regulatory compliance.

Qualifications

• 3‑5 years of experience in CAPA management, compliance, quality systems, audit coordination, or a related field.
• Experience within the pharmaceutical, biotechnology, or life sciences industry.
• Working knowledge of GxP requirements and regulated quality environments.
• Experience supporting audits, inspections, investigations, or compliance programs.
• Strong organizational, communication, and stakeholder‑management skills.
• Ability to identify and mitigate compliance‑related risks.
• Proficiency with Microsoft Office and quality management systems.

Preferred Qualifications

• Experience supporting global teams and stakeholders.
• Familiarity with inspection readiness and regulatory audits.
• Experience with electronic quality management systems (eQMS) and CAPA tracking tools.
• Knowledge of Medical Affairs or healthcare compliance processes.