Technology Quality Oversight Specialist

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **TECHNOLOGY QUALITY OVERSIGHT SPECIALIST** **About the Role** Join Parexel's Technology Quality team to support quality oversight across our technology solution lifecycle. You'll provide validation expertise, risk assessment support, compliance monitoring, and inspection readiness for GxP and business-critical systems. Partner with business stakeholders, Solution Validation Services, Digital and Technology, and Corporate Quality to ensure technology solutions remain compliant, fit for intended use, and inspection-ready throughout their lifecycle. **Key Responsibilities** * Provide quality oversight for technology solution development, validation, implementation, and maintenance. * Independently review validation packages, including requirements, risk assessments, testing evidence, traceability, and validation reports to ensure compliance and inspection readiness. * Monitor compliance with regulatory requirements, industry standards, and established procedures. * Serve as a Quality Representative for technology quality issues, audit findings, CAPAs, and compliance initiatives, partnering with stakeholders to drive timely and effective resolution. * Facilitate root cause analysis activities, remediation planning, and CAPA development to address technology-related compliance and validation issues. * Assess AI-enabled solutions and emerging technologies for quality and compliance. * Support customer audits, regulatory inspections, and internal audits by serving as a technology quality subject matter expert and facilitating responses to validation and compliance inquiries. * Assist with supplier and vendor quality assessments. * Maintain inspection-ready documentation and support audit readiness. **What We're Looking For** **Required Experience**  • 3–5 years in computerized system validation, technology quality, clinical research, pharmaceutical quality, or GxP-regulated environments • Experience supporting technology projects and validation activities • Knowledge of SDLC, validation lifecycle, change control, CAPA, and risk management **Key Skills**  • Working knowledge of computerized system validation principles • Understanding of GxP regulations (GCP, electronic records/signatures) • Knowledge of risk management and quality systems • Strong analytical, problem-solving, and communication skills • Excellent stakeholder management abilities • Ability to prioritize multiple activities in a fast-paced global environment **Preferred Qualifications** • Experience with Veeva, ServiceNow, Power BI, or AI-enabled systems • Audit or inspection support experience • Knowledge of GAMP 5, Computer Software Assurance, or AI governance principles **Education** Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Pharmacy, Quality Management, or related discipline; or equivalent combination of education and relevant experience. **Why Join Parexel?** Be part of a global Clinical Research Organization committed to quality and compliance. Support cutting-edge technology solutions while building expertise in GxP validation and emerging technologies like AI.