パレクセルでの仕事
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Technology Quality Oversight Specialist
応募 求人ID R0000044239 ロケーション リトアニア共和国 仕事内容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.
