QA Consultant

Role: Quality Assurance (QA) ConsultantIndustry: 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 ResponsibilitiesSupport 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. QualificationsBachelor'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. PreferredLead Auditor certification Experience with electronic QMS platforms

Created: 2026-03-04