Technology Quality Oversight Specialist

**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.

**Required Experience** **What We're Looking For**

* 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.