Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Technology Quality Oversight Specialist
🔥 0 minutes ago
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Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
📋 Description
• 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.
🎯 Requirements
• 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 • 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 • 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.
🏖️ Benefits
• Support cutting-edge technology solutions while building expertise • Collaborative work environment • Opportunity to improve the world’s health
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