Systems Validation Specialist II

Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient‑focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry‑leading innovation,
With Heart®.

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, and 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, and risk management while contributing to clinical research across multiple phases of drug development.

• 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.
• Work with management and peers across the business to 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 the validation and release of interfaces and solutions.
• Lead activities with business and team leads to identify low‑ and medium‑risk or value improvements for process architecture, subject to quality oversight, 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 a project, business area, or portfolio, including requirements for validation planning, resource estimates, risk and impact assessments, summary reporting, and Electronic Records/Electronic Signature regulations where applicable.
• 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.

You’ll thrive in this role if you bring:

• Stre…