Systems Validation Specialist II

🔥 5 hours ago

🌐 Argentina, Mexico – Remote

🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 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

• Act as a custodian and leader of the Parexel Quality System and serve as an ambassador for quality across the business and with customers • Support the development, implementation, and management of Parexel strategic objectives • Establish and maintain a communication framework that removes constraints and supports timely, effective action on quality matters • Collaborate with functional leads to design, re-engineer, implement, and adopt the quality framework for validation and release of interfaces and solutions • Lead activities to identify low- and medium-risk or value improvements for process architecture, including Standard Operating Procedures, manuals, and related quality system documentation • Support the development, implementation, continuous improvement, training, and adoption of infrastructure, change control, and problem management processes • Provide guidance, consultation, and quality expertise to project teams supporting clinical trial and validation activities across the applicable lifecycle • Support oversight and monitoring of compliance status and activities for projects, business areas, or portfolios, including validation planning, resource estimates, risk and impact assessments, summary reporting, and Electronic Records/Electronic Signature regulations • Assist with risk mitigation by identifying, categorizing, and defining risks and associated mitigation plans • Support internal customers with technology-related Quality Issue management, including issue descriptions, classification, root cause analysis oversight, and consultation on corrective and preventive actions

🎯 Requirements

• 3+ years of experience in clinical research and/or clinical trials with emphasis on GCP and technology compliance • Familiarity with technology as it relates to clinical trial activities, including the System Life Cycle process and applicable GCP regulations pertaining to computer systems • Basic knowledge of continuous improvement methodologies • Competency across core project management activities • Degree-level education in technology, biological science, pharmacy, or another health-related discipline preferred; an equivalent qualification • High ability to prioritize workload and manage multiple and varied tasks with enthusiasm • Mid-level experience in computer technology quality and compliance and the pharmaceutical industry across multiple disciplines within Clinical Drug Development and/or Manufacturing • Excellent interpersonal, verbal, and written communication skills • Business understanding and negotiation skills • Strong organizational skills • Ability to work in a customer-focused, fast-paced, rapidly changing, and global environment • Intermediate desktop software skills, including MS Office, Excel, and Adobe PDF • Experience across Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing preferred • Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies preferred • Cultural awareness and ability to think and work globally preferred

🏖️ Benefits

• Flexible work arrangements, including remote work • Opportunities for professional growth and to deepen expertise in computerized system validation, technology compliance, quality systems, project management, auditing, and risk management • Opportunities to contribute to clinical research across multiple phases of drug development