Role: Quality Assurance (QA) Consultant

Industry: Pharmaceutical / Clinical Data Management
Engagement: Consulting (Contract or Fractional)

Role Overview

The QA Consultant provides quality system and compliance support to a pharmaceutical Clinical Data Management organization. The role focuses on QMS maintenance, internal and external auditing, vendor oversight, and inspection readiness to ensure compliance with applicable GxP regulations.

Key Responsibilities

• Support development, maintenance, and continuous improvement of the Quality Management System (QMS).

• Conduct internal audits and support external/vendor audits; document findings and track CAPAs.

• Provide compliance oversight for clinical data management processes and computerized systems.

• Support inspection readiness, mock audits, and regulatory or client inspections.

• Advise on deviations, CAPAs, change control, risk management, and data integrity.

• Collaborate with internal teams and external partners to address compliance gaps and implement improvements.

Qualifications

• Bachelor’s degree in Life Sciences or related field.

• 7+ years of QA experience in pharmaceuticals, clinical research, CROs, or regulated environments.

• Strong working knowledge of GxP, ICH, FDA/EMA expectations, and clinical data management processes.

• Proven experience with QMS management and auditing.

• Strong communication skills and ability to work independently in a consulting role.

Preferred

• Lead Auditor certification

• Experience with electronic QMS platforms