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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Quality and Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and CSV standards. Proficient in developing and executing validation plans, test scripts, and system documentation while facilitating communication between IT and business stakeholders.
Highest-signal resume keywords
Quality And Regulatory IT Applications ManagementGxP And 21 CFR Part 11 ComplianceValidation Plans And Test Scripts DevelopmentVeeva And TrackWise ExperienceSQL And System Integration Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Business AnalysisSystem ValidationTest Script DevelopmentApplication ConfigurationRisk AssessmentChange ManagementRegulatory ComplianceUser Acceptance Testing (UAT)Cloud Application DeploymentSaaS Environments
Soft Skills
Analytical SkillsProblem-SolvingCommunication SkillsCollaborationAttention To Detail
Tools & Technologies
VeevaTrackWiseLabVantage LIMSAWSAzureVeeva VaultSalesforceDigital Transformation ToolsQuality Management Systems (QMS)Validation Tools
Industry Keywords
Life SciencesPharmaceuticalMedical DeviceComputer System Validation (CSV)Regulatory StandardsGlobal Regulatory ComplianceISO 13485FDA RegulationsAgile MethodologiesWaterfall Methodologies
Tech Stack
Tools & technologiesAWSAzureCloudJavaSQLVault.NET
About the role
Key responsibilities & impact- Own and manage Quality and Regulatory IT applications
- Serve as functional business analyst by gathering and analyzing business needs and defining requirements
- Architect and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications
- Lead system validation, testing execution, and change management in a regulated environment
- Maintain compliance with GxP, 21 CFR Part 11, CSV, FDA, ISO 13485, and global regulatory standards
- Maintain functional requirements, design specifications, validation plans, and change control records
- Ensure systems remain in a validated state throughout their lifecycle
- Develop and execute test scripts, UAT scenarios, and validation plans
- Manage risk assessments, audits, and regulatory inspections related to validation and compliance
- Oversee system upgrades, patches, maintenance, defect triage, root cause analysis, and issue resolution
- Liaise between IT, Quality, Regulatory, business process owners, and external vendors
- Support global Quality and Regulatory IT projects and digital transformation initiatives
- Provide end-user training and support
- Assist with project management and coordinate timely delivery of IT solutions
Requirements
What you’ll need- Bachelor’s degree in Computer Science, Information Systems, or a related field
- 3+ years of experience in IT business analysis, system ownership, or validation in Life Sciences/Pharmaceutical/Medical Device industry
- Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications
- Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and regulatory compliance
- Ability to develop and execute test scripts, validation plans, and system documentation
- Technical knowledge of SQL, system integrations, and application configuration
- Spanish and English speaking and written communication skills are mandatory
- Basic understanding of Java, .NET, and SQL
- Knowledge of AWS or Azure and cloud application deployment, configuration, and maintenance
- Experience with CSV, GxP requirements, and writing and executing IQ/OQ/PQ scripts
- Familiarity with SaaS environments, Veeva Vault Platform, Salesforce-based systems, workflows, lifecycles, and user permissions
- Hands-on experience with Veeva Vault QMS or TrackWise Digital
- Understanding of regulatory processes and submissions
- Analytical, problem-solving, communication, collaboration, and attention-to-detail skills
- Preferred: Experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments
- Preferred: Basic project management experience with Agile, Waterfall, or hybrid methodologies
Benefits
Comp & perks- Reasonable accommodations for individuals with disabilities globally
- Remote position
- End-user training and support