系统验证专员II

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel

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®.
About the Role
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.

Key Responsibilities

• 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.

Candidate Profile
You’ll thrive in this role if you bring:

• 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

Required Qualifications

• 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

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

Originally posted on Himalayas