RC-REGULATORY COMPLIANCE-CSV-Quality Lead-Manager

EY GDS Consulting Enterprise Risk - ER Regulatory Compliance Senior- CSV-QA Lead - Manager

At EY were all in to shape your future with confidence.

Well help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.

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 Manager actively establish maintain and strengthen internal and external line with our commitment to quality youll 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 a highly experienced and detail-oriented Manager Computerized System Validation (CSV)/ QA Lead to lead and manage validation & Compliance activities for GxP-regulated computerized systems across 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. This role involves leadership client engagement and mentoring teams while maintaining validated systems throughout their lifecycle.

Your Key Responsibilities

• Lead validation efforts for GxP systems using a risk-based approach aligned with GAMP 5 and System Development Life Cycle (SDLC).
• Define CSV strategy perform software classification IT risk assessments and develop mitigation plans.
• Conduct gap assessments and remediation for legacy systems to align with lifecycle validation principles.
• Oversee business process transformation initiatives involving systems like SAP LIMS ELN MES Documentum TrackWise Veeva Vault ValGenesis Argus and RIMS.
• Troubleshoot IT application issues and provide strategic recommendations in collaboration with stakeholders.
• Author and review validation deliverables: URS FRS Validation Plans IQ/OQ/PQ protocols Traceability Matrix and Final Reports.
• Ensure documentation meets internal SOPs and external regulatory expectations.
• Maintain audit-ready documentation and ensure data integrity throughout the system lifecycle.
• Act as Subject Matter Expert (SME) during internal audits and external inspections; address findings and implement CAPAs.
• Stay current with evolving regulatory guidelines and industry best practices.
• Collaborate with clients to develop validation strategies that meet engagement objectives and compliance standards.
• Drive business development activities proposals and client engagement strategies.
• Create innovative insights and contribute to thought leadership and knowledge-sharing initiatives.
• Manage periodic reviews revalidation and system retirement activities to ensure validated state.
• Review project status updates and prepare management presentations.
• Provide training mentoring and cross-skilling of project resources.
• Foster teamwork and a positive learning culture across service lines.

Qualifications

• Bachelors or Masters degree in Life Sciences Engineering or related field.
• 812 years of experience in CSV within the pharmaceutical industry or consulting environment with 35 years in a leadership role.
• Strong knowledge of GxP GAMP 5 21 CFR Part 11 and Annex 11.
• Hands-on experience with regulated systems such as SAP LIMS MES ELN Veeva Vault.
• Excellent communication documentation and stakeholder management skills.

Must-Have Skills & Attributes

• Expertise in CSV documentation: URS FRS IQ/OQ/PQ Traceability Matrix Validation Plans.
• Risk assessment & software classification for IT systems.
• Gap analysis & remediation for legacy systems.
• Audit readiness and experience supporting regulatory inspections.
• Hands-on experience with SAP LIMS ELN MES Documentum TrackWise Veeva Vault ValGenesis Argus RIMS.
• Familiarity with AI/ML model lifecycle.
• Understanding of data integrity principles and electronic records/e-signatures compliance.
• Ability to collaborate with cross-functional teams (QA IT Manufacturing Labs).
• Proven ability to mentor junior staff and lead validation teams.
• Strong project management and client-facing skills.
• Experienced in Agile Projects and CSM certification is mandatory

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies.
• Ability to create innovative insights and contribute to thought leadership.
• Experience in process optimization and operational efficiency initiatives.
• Ability to align technology with business transformation goals.
• High attention to detail and analytical thinking.
• Adaptability to changing regulatory and business environments.
• Strong problem-solving and decision-making abilities.

Preferred Certifications

• Certified Software Quality Engineer (CSQE) Certified Software Quality Assurance (CSQA).
• ISO 9001:2015 Lead Auditor Quality Auditor Certification (CQA).
• Information Security or Risk Management 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

At EY were 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 thats right for you