Technology Quality Oversight Specialist

Summary

Parexel is a global Clinical Research Organization committed to quality and compliance. The Technology Quality Oversight Specialist will support quality oversight across technology solutions, ensuring compliance and inspection readiness throughout their lifecycle.

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

Skills

• 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
• 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

Qualifications

Must Haves

• 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

Nice to Haves

• 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

Benefits

• Employment_type: Remote