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Technology Quality Oversight Specialist
ParexelQuality Oversight Specialist supporting quality oversight for technology solutions at Parexel, contributing to the improvement of the world’s health. Collaborating with stakeholders to maintain compliance and inspection readiness.
Core Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates expertise in Computerized System Validation, Quality Oversight, and Compliance within GxP-regulated environments, ensuring adherence to industry standards and effective resolution of quality issues. Proficient in stakeholder management and capable of supporting technology projects and validation activities in fast-paced settings.
ATS Keywords
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Support cutting-edge technology solutions while building expertise
- Collaborative work environment
- Opportunity to improve the world’s health