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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer System Validation (CSV) and risk-based validation strategies for cloud/SaaS platforms, particularly Veeva Vault, while ensuring compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11. Proven ability to lead validation efforts, support audits, and collaborate effectively with cross-functional teams.
Highest-signal resume keywords
Computer System Validation (CSV)Risk-Based Validation StrategiesVeeva Vault ValidationGAMP 5 ComplianceRegulatory Inspection Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk AssessmentValidation PlanningTest Evidence ReviewCloud/SaaS ValidationGxP Environment ExperienceValidation Summary ReportingValidation SME SupportPolicy/SOP Framework DevelopmentTest Automation CollaborationRegulatory Compliance
Soft Skills
Influencing SkillsRelationship BuildingProject ManagementOperational EfficiencyProactive Risk Identification
Tools & Technologies
Veeva VaultVeeva QualityQualityDocsQMS
Certifications & Qualifications
ISPE GAMP 5 CertificationCSQE CertificationCSQA CertificationInformation Security CertificationRisk Management Certification
Industry Keywords
21 CFR Part 11EU Annex 11FDA CSA GuidancePharmaceuticalLife SciencesConsulting
Tech Stack
Tools & technologiesCloudVault
About the role
Key responsibilities & impact- Define CSA/CSV strategy and risk-based validation approach for the Veeva Vault platform
- Perform risk assessments on configuration, integration, and release changes
- Define validation and testing evidence requirements with QA Engineering
- Review and approve validation plans, risk assessments, test evidence, and validation summary reports
- Ensure platform changes comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and internal CSV policies
- Provide compliance guidance to internal leads and vendor team members
- Support audits and health authority inspections as the platform validation SME
- Partner with QA and Change Management on validation justification and evidence
- Monitor evolving CSA guidance and advise the Center of Excellence on policy updates
- Establish, maintain, and strengthen internal and external relationships
- Drive projects to completion with high-quality deliverables and operational efficiency
- Proactively identify and raise risks with clients and EY senior management
- Lead internal initiatives
Requirements
What you’ll need- Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field
- 5+ years in Computer System Validation within pharmaceutical, life sciences, or consulting organizations
- Comfortable working with distributed teams across India, Prague, and US time zones
- Strong influencing skills to drive practice change from CSV to CSA
- Deep knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11
- Experience defining risk-based testing/validation strategies
- Experience validating cloud/SaaS platforms in a GxP environment; Veeva Vault strongly preferred
- Experience supporting regulatory inspections/audits as a validation SME
- Experience partnering with QA/Test Automation teams on risk assessments and automated test coverage
- Prior Veeva Vault implementation validation experience preferred
- Experience building or updating CSA policy/SOP frameworks preferred
- Experience with Veeva Vault QMS/QualityDocs preferred
- ISPE GAMP 5 training/certification preferred
- CSQE or CSQA certification preferred
- Information Security or Risk Management certification preferred
- Veeva Quality certification preferred
Benefits
Comp & perks- Support, coaching and feedback from engaging colleagues
- Opportunities to develop new skills and progress your career
- Education and coaching alongside practical experience
- Individual progression plan
- Freedom and flexibility to handle the role in a way that’s right for you
- Inspiring and meaningful projects
- Interdisciplinary environment emphasizing high quality and knowledge exchange