RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –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’ll 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 Senior CSV/Quality lead Specialist to lead and manage validation activities for GxP-regulated computerized systems. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and support cross-functional teams in implementing and maintaining validated systems across the pharmaceutical lifecycle. This role also involves strategic client engagement, business process transformation, and operational excellence.

Your key responsibilities

• Lead validation efforts for GxP systems using a risk-based approach aligned with GAMP 5 and the system development life cycle.
• Perform software classification, IT risk assessments, and define mitigation strategies.
• Conduct gap assessments and remediation for legacy systems to align with lifecycle validation principles.
• Support business process transformation initiatives involving systems like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, and RIMS.
• Troubleshoot IT application issues and recommend solutions in collaboration with relevant 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 SME during internal audits and external inspections.
• Address audit findings and implement effective CAPAs.
• Stay current with evolving regulatory guidelines and industry best practices.
• Collaborate with clients to develop validation strategies that meet engagement objectives and regulatory standards.
• Assist senior managers in driving business development and delivering client engagements efficiently.
• Create innovative insights and contribute to thought leadership and knowledge-sharing initiatives.
• Evaluate and validate changes to existing systems through impact assessments.
• Manage periodic reviews, revalidation, and system retirement activities.
• Ensure systems remain in a validated state throughout their operational lifecycle.
• Contribute to improving operational efficiency on projects and internal initiatives.
• 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.
• Demonstrate detailed knowledge of market trends, competitor activities, and service offerings.
• Maintain strong client focus and build productive relationships with client personnel.
• Stay abreast of current business and economic developments relevant to the pharmaceutical industry.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
• 4-9 years of experience in CSV within the pharmaceutical industry or consulting environment.
• Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, and Annex 11.
• Experience with regulated systems such as SAP, LIMS, MES, ELN, and Veeva Vault.
• Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

• Strong knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11)
• GAMP 5 methodology and system development life cycle (SDLC)
• CSV documentation: URS, FRS, IQ/OQ/PQ, Traceability Matrix, Validation Plans
• Risk assessment & software classification for IT systems
• Gap analysis & remediation for legacy systems
• Good knowledge of Quality concepts with detail experience in root cause analysis, deviation management, CAPA implementation.
• Audit readiness and experience supporting regulatory inspections
• Hands-on experience with SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, RIMS
• Understanding of data integrity principles and electronic records/e-signatures compliance
• Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs)
• Experience in client-facing roles, managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Ability to troubleshoot application issues and recommend solutions
• Familiarity with change control, deviation handling, and CAPA processes
• Proven ability to mentor junior staff and lead validation teams
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Ability to create innovative insights and contribute to thought leadership
• Understanding of market trends and competitor landscape
• 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

Ideally, you’ll also have

• 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, we’re dedicated to helping our clients, from start–ups 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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