Regulatory Compliance Senior - Multiple Teams

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

As part of our EY – ER - Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you will consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The Opportunity

We are seeking an experienced Senior Consultant (Validation/Tester – Veeva) to lead validation, testing activities and compliance across various Veeva modules, regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.

Your Key Responsibilities

• Define CSA/CSV strategy in collaboration with Governance & Vaidation Lead and risk-based validation approach for the Veeva Vault platform, balancing modern CSA principles (critical thinking, risk-based test coverage) with CSV rigor where required for specific vaults/regulatory contexts.
• Perform risk assessments on platform changes (configuration, integration, releases) to determine appropriate validation rigor and evidence requirements per change.
• Define validation/testing evidence requirements in partnership with the QA Engineer role — ensuring test coverage decisions are risk-justified and audit-defensible.
• Review and approve validation deliverables (validation plans, risk assessments, test evidence, validation summary reports) before closure.
• Ensure platform changes comply with applicable regulations (21 CFR Part 11, EU Annex 11, GAMP 5) and internal Computerized System Validation policies.
• Provide compliance guidance to internal Leads and vendor team members on how CSA principles apply to specific configuration/integration scenarios.
• Support internal/external audits and health authority inspections — act as the platform's validation SME during inspection readiness and response.
• Partner with QA/Change Management to ensure Change Control records carry appropriate validation justification and evidence.
• Stay current on evolving CSA guidance (e.g., FDA's CSA draft guidance) and industry practice, advising the CoE on policy updates.

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.
• Comfortable working with distributed teams across India, Prague, and US time zones.
• Strong influencing skills to drive practice change (CSV → CSA) across a delivery team that includes multiple other vendor roles.

Must-Have Skills & Attributes

• 5+ years of experience in Computer System Validation, with demonstrated leadership transitioning teams from traditional CSV to CSA practices.
• 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 that reduce documentation/testing burden without compromising compliance.
• Experience validating cloud/SaaS platforms (Veeva Vault experience strongly preferred) in a GxP environment.
• Experience supporting regulatory inspections/audits as a validation SME.
• Strong stakeholder influencing skills — this role must drive adoption of CSA thinking across delivery teams (Configuration, Integration, QA) who may default to legacy CSV habits.
• Experience partnering with QA/Test Automation teams to align risk assessments with automated test coverage decisions.

Good-to-Have Skills & Attributes

• Prior experience specifically validating Veeva Vault implementations (any vault — Clinical, RIM, QMS, Safety, Medical, CRM).
• Experience building or updating an organization's CSA policy/SOP framework.
• Experience with Veeva Vault QMS/QualityDocs as the vehicle for validation documentation.
• ISPE GAMP 5 training/certification

Preferred Certifications

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• Information Security or Risk Management certifications.
• Any Veeva Quality certification.

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

At EY, we’re dedicated to helping our clients, from startups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• 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

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