Systems Validation Specialist II

Parexel

. Act as a custodian and leader of the Parexel Quality System and serve as an ambassador for quality across the business and with customers .

Posted 9/29/2026full-timeRemote • Argentina, MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality System management, compliance with GCP regulations, and project management within clinical research. Proficient in risk assessment, continuous improvement methodologies, and effective communication in a global, customer-focused environment.

Highest-signal resume keywords

Clinical Research ExperienceGCP ComplianceQuality System ManagementProject ManagementRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Continuous Improvement MethodologiesClinical Trial ActivitiesValidation PlanningChange Control ProcessesProblem Management ProcessesRisk AssessmentQuality Issue ManagementStandard Operating ProceduresComputer Technology QualityClinical Drug Development

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsNegotiation SkillsAbility to Prioritize Workload

Tools & Technologies

MS OfficeExcelAdobe PDF

Industry Keywords

Clinical TrialsPharmaceutical IndustryLean Six SigmaAuditingElectronic RecordsElectronic Signature Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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