[Hiring] Systems Validation Specialist @Parexel

Role Description

We are seeking a Systems Validation Specialist to join our team in Argentina or Mexico in a remote capacity. As a Systems Validation Specialist, you will support the definition, adoption, and oversight of compliant processes and standards that form the baseline for technology solution development, validation, and delivery. You will collaborate with business and functional stakeholders to support:

• Quality frameworks
• Technology solution project quality oversight
• Continuous process improvement
• Audit and inspection activities
• Quality and GxP regulatory guidance

Through this work, you will help maintain compliant technology solutions that support clinical research and the delivery of new therapies to patients. You’ll join a fast-paced, growth-oriented environment where quality, collaboration, and continuous improvement are central to organizational success. This role offers opportunities to deepen your expertise in:

• Computerized system validation
• Technology compliance
• Quality systems
• Project management
• Auditing
• Risk management

Qualifications

• Strengths in quality and compliance, computerized system validation, and continuous process improvement
• 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, negotiation skills, and strong organizational skills
• The ability to work in a customer-focused, fast-paced, rapidly changing, and global environment while prioritizing multiple and varied tasks
• Intermediate desktop software skills, including MS Office, Excel, and Adobe PDF

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 and 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

Preferred Qualifications

• Degree in technology, biological science, pharmacy, or another health-related discipline
• Experience across Clinical Drug Development Phases I, II, III, and/or IV and/or Manufacturing
• Knowledge of project management, Lean Six Sigma, auditing, and/or risk management methodologies
• Cultural awareness and the ability to think and work globally