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Senior Regulatory Compliance, CSV, Veeva
EYSenior Consultant leading validation and compliance activities across Veeva QMS modules for global pharmaceutical clients. Ensuring adherence to regulatory standards while driving strategic initiatives.
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
- Integrate validation and testing into Agile delivery models, ensuring compliance is embedded within iterative development cycles
- Oversee AI/ML governance and validation, including model risk management, data integrity, explainability, and compliance with emerging regulatory expectations
- Conduct impact assessments, gap assessments, and remediation for legacy and transforming systems
- 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
- Ensure data integrity and inspection readiness across systems
- Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards
Requirements
What you’ll need- Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field
- 5+ 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 stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams
- 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
CSVCSAvalidationtestingcompliancerisk-based testingFunctional TestingUser Acceptance Testingdata integrityimpact assessments
Soft Skills
communicationdocumentationstakeholder managementproject managementproblem solvingcoachingguidancecollaboration