Search Remote Jobs

Technology Quality Oversight Specialist

Likely ghost job

🕒 July 31

🌐 Lithuania, Croatia, +4 more countries – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

✹ Quality Specialist

Where this job comes from

Posted on Parexel's careers page, not through a job board

First seen by Remote Rocketship July 31

Still open on Parexel's site. Checked 4 hours ago.

Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ 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 ‱ 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 ‱ Partner with stakeholders to drive timely and effective resolution ‱ Facilitate root cause analysis, remediation planning, and CAPA development ‱ Assess AI-enabled solutions and emerging technologies for quality and compliance ‱ Support customer audits, regulatory inspections, and internal audits as a technology quality subject matter expert ‱ Facilitate responses to validation and compliance inquiries ‱ Assist with supplier and vendor quality assessments ‱ Maintain inspection-ready documentation and support audit readiness ‱ Partner with business stakeholders, Solution Validation Services, Digital and Technology, and Corporate Quality throughout the technology solution lifecycle

🎯 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 ‱ Preferred: Experience with Veeva, ServiceNow, Power BI, or AI-enabled systems ‱ Preferred: Audit or inspection support experience ‱ Preferred: Knowledge of GAMP 5, Computer Software Assurance, or AI governance principles

đŸ–ïž Benefits

‱ Support cutting-edge technology solutions while building expertise in GxP validation and emerging technologies like AI ‱ Opportunity to be part of a global Clinical Research Organization committed to quality and compliance

Apply Now

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com
Follow Remote Rocketship on LinkedInFollow Remote Rocketship on InstagramFollow Remote Rocketship on FacebookFollow Remote Rocketship on TikTok