RC-REGULATORY COMPLIANCE-CSV-Senior

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – CSV - Senior

The Opportunity

Your Key Responsibilities

• Lead validation, testing and compliance activities across 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 GxP systems.
• Serve as a trusted advisor to clients across critical 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.

Qualifications

• 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.

Skills

• Strong expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans.
• 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.

Must-Have Skills & Attributes

• 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 various 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

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies.
• Automation testing experience with tools like Tricentis Tosca, Selenium, Leapwork, etc. is an added advantage.
• Experience with QMS platforms such as Veeva, TrackWise, MasterControl and ETQ Reliance.
• Understanding of AI/ML lifecycle, governance and validation skills.
• Ability to align technology with business transformation goals.
• High attention to detail and analytical thinking.
• Familiarity with emerging regulatory trends, such as CSA or digital validation approaches.
• Adaptability to changing regulatory and business environments.

Preferred Certifications

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries.

What working at EY offers

Equal opportunity information

About EY