Technology Quality Oversight Specialist

About the role

Parexel’s Technology Quality team is looking for a specialist to oversee quality across the lifecycle of technology solutions. You will provide validation expertise, risk assessment support, and ensure compliance with GxP and business‑critical requirements.

Key responsibilities

• Provide quality oversight for technology solution development, validation, implementation, and maintenance.
• Review validation packages—including requirements, risk assessments, testing evidence, traceability, and reports—to ensure inspection readiness.
• Monitor compliance with regulatory requirements, industry standards, and internal procedures.
• Act as Quality Representative for technology issues, audit findings, CAPAs, and compliance initiatives.
• Facilitate root‑cause analysis, remediation planning, and CAPA development.
• Assess AI‑enabled and emerging technologies for quality and compliance.
• Support customer audits, regulatory inspections, and internal audits as a subject‑matter expert.
• Assist with supplier and vendor quality assessments and maintain inspection‑ready documentation.

Required profile

• 3–5 years of experience in computerized system validation, technology quality, clinical research, pharmaceutical quality, or other GxP‑regulated environments.
• Hands‑on experience supporting technology projects and validation activities.
• Knowledge of SDLC, validation lifecycle, change control, CAPA, and risk management.

Required skills

• Working knowledge of computerized system validation principles.
• Understanding of GxP regulations (GCP, electronic records/signatures).
• Familiarity with risk management and quality systems.

What we offer

• Opportunity to work in a global clinical research organization committed to quality and compliance.
• Exposure to cutting‑edge technology solutions and GxP validation practices.