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Regulatory Compliance, Veeva, Staff
EYRegulatory Compliance Staff leading validation and testing activities across Veeva QMS modules at EY. Collaborating with clients to ensure compliance with global regulatory standards in the pharmaceutical sector.
About the role
Key responsibilities & impact- Lead validation, testing and compliance activities across Veeva QMS modules and other GxP and non-GxP systems, aligning with global regulatory requirements and client objectives
- Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models
- Author and review deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports
- Develop and execute risk-based testing strategies, test scripts for Functional Testing & User Acceptance Testing of Veeva QMS and other GxP systems
- Serve as a trusted advisor to clients across critical Veeva QMS quality processes, including change management, CAPA, deviations, investigations, and associated documentation, helping deliver compliant solutions and high-quality deliverables
Requirements
What you’ll need- Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field
- 2+ years in CSV within the pharmaceutical, life sciences or consulting organizations
- Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11
- Consulting or client‑facing experience preferred
- Excellent communication, documentation, and stakeholder management skills
- Strong expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans
- Proven experience in validation, testing and compliance activities across Veeva QMS modules and other GxP and non-GxP systems
- Strong experience in development and execution of test scripts for Functional Testing, User Acceptance Testing of GxP systems
- Experience with tools like Jira, Confluence and test management tools like qTest, HP ALM, Xray, Valgenesis, etc.
- Experience working in Agile delivery models
- Strong project management, problem solving and communication skills
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CSVCSAGxPVeeva QMSRisk AssessmentsValidation PlansFunctional TestingUser Acceptance TestingGap AnalysisTraceability Matrix
Soft Skills
communicationdocumentationstakeholder managementproject managementproblem solving