RC-REGULATORY COMPLIANCE-CSV-QA -Senior Full Time NEW

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

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 skilled Senior CSV & Scrum Delivery Specialist with strong expertise in GxP system validation and Agile delivery activities. The ideal candidate will ensure compliance with global regulations (FDA, EMA, MHRA), support cross‑functional teams, and drive the implementation and maintenance of validated systems across the pharmaceutical lifecycle, including Veeva Vault Quality, Clinical, and RIM. This role also involves client engagement, process optimization, and enabling operational excellence within regulated Agile environments.

Your Key Responsibilities

• Lead validation activities for GxP and non GxP systems using a risk‑based approach aligned with GAMP 5 and SDLC principles.
• Perform software classification, IT risk assessments, and define mitigation strategies.
• Conduct gap assessments and remediation for legacy or non‑compliant systems.
• Author and review core validation deliverables (URS, FRS, Validation Plans, IQ/OQ/PQ, Traceability Matrix, Final Reports).
• Maintain audit‑ready documentation and ensure end‑to‑end data integrity throughout the system lifecycle.
• Act as SME during internal audits and regulatory inspections, driving CAPA implementation.
• Support transformation initiatives involving enterprise systems (SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, RIMS).
• Lead data migration, integration, and system connectivity activities across validated platforms.
• Evaluate and validate system changes through structured impact assessments.
• Manage periodic reviews, revalidation, and system retirement activities.
• Facilitate all Agile/Scrum ceremonies (daily stand‑ups, sprint planning, refinement, reviews, retrospectives).
• Coach and mentor teams on Agile principles, Scrum best practices, and self‑organization.
• Support Product Owners with backlog grooming, prioritization, and defining acceptance criteria.
• Remove impediments and coordinate resolution across cross‑functional business and technical teams.
• Maintain Agile metrics (velocity, burndown charts, RAID logs, dashboards) to ensure delivery transparency.
• Foster a collaborative, trust‑based team culture that encourages open communication and continuous improvement.
• Ensure sprint deliverables (configs, test evidence, requirements) comply with validation and documentation standards.
• Align business stakeholders, technical teams, and validation leads on sprint goals and regulatory expectations.
• Identify process improvements and embed actionable items into sprint cycles.
• Troubleshoot system or application issues and coordinate with SMEs for resolution.
• Develop validation and Agile delivery strategies aligned with client objectives and regulatory requirements.
• Prepare project updates, leadership presentations, and status communications.
• Mentor, train, and upskill team members across validation, compliance, and Agile practices.
• Maintain strong client focus, build trusted relationships, and support business development initiatives.
• Stay abreast of emerging industry trends, regulatory changes, and technology advancements relevant to Life Sciences.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Computer Science, Engineering, or a related technical field.
• 5–8 years of experience in Computer System Validation (CSV), GxP system implementation, or regulated IT delivery within the pharmaceutical/life sciences industry.
• Certified Scrum Master (CSM), SAFe Scrum Master, or equivalent Agile certification ( preferred).
• Strong understanding of GxP regulations, GAMP 5, 21 CFR Part 11, Annex 11, and data‑integrity principles.
• Hands‑on experience with regulated platforms such as Veeva Vault, SAP, LIMS, MES, ELN, Documentum, TrackWise, or ValGenesis.
• Proven experience working in Agile/Scrum environments and facilitating Scrum ceremonies.

Must-Have Skills & Attributes

• Strong knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data‑integrity principles.
• Hands‑on understanding of GAMP 5 methodology and the full system development life cycle (SDLC).
• Proficiency in CSV documentation including URS, FRS, IQ/OQ/PQ, Traceability Matrix, and Validation Plans.
• Scrum master certification and proven experience handling scrum teams and scrum ceremonies.
• Experience on performing risk assessments, software classification, and impact assessments for IT/validated systems.
• Ability to conduct gap analysis, remediation planning, and lifecycle management for legacy and regulated systems.
• Audit readiness expertise with experience supporting regulatory inspections and managing CAPA responses.
• Hands‑on experience with regulated platforms such as Veeva Vault, SAP, LIMS, ELN, MES, Documentum, TrackWise, ValGenesis, Argus, and RIMS.
• Experienced in Agile/Scrum environments with the ability to facilitate ceremonies, coach teams, and drive continuous improvement.
• Strong understanding of Agile metrics, backlog management, sprint execution, and cross‑functional collaboration.
• Ability to collaborate effectively with QA, IT, Manufacturing, Labs, business stakeholders, and Product Owners.
• Experience in client‑facing roles, managing expectations, requirements, and delivery outcomes.
• Excellent written and verbal communication skills, with strong documentation and presentation capabilities.
• Experience in IT project management, validation planning, and coordinating deliverables across teams.
• Ability to troubleshoot system/application issues and coordinate resolution with SMEs.
• Familiarity with change control, deviation management, CAPA workflows, and quality governance.
• Proven ability to mentor junior staff and lead validation or Agile delivery teams.
• Experienced in training and cross‑skilling resources on Agile practices and validation standards.
• Strong teamwork orientation and the ability to foster a positive, collaborative team culture.

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

• Agile/Scrum Certifications such as SAFe® Scrum Master (SSM), Professional Scrum Master (PSM I/II), or Advanced CSM
• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
• Lean Six Sigma (Yellow/Green Belt)

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

EY | Building a better working world

EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.