RC-REGULATORY COMPLIANCE-CSV-QA -Senior Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Manager – CSV/QA Lead

At EY, we’re all in to shape your future with confidence.

We’ll 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 Senior Manager 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 Manager – Computerized System Validation (CSV) to lead and manage validation 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. 

Role Overview

As a Senior Manager – Computer System Validation (CSV), you will lead the GxP validation, implementation. Quality and compliance of IT systems within highly regulated GxP environments, ensuring that all solutions meet stringent compliance, quality, and industry standards. Leveraging your deep expertise in Computer System Validation, GxP regulations, and lifecycle documentation, you will guide clients through complex validation initiatives while ensuring alignment with business and regulatory expectations.

Your primary responsibility will be to collaborate closely with clients to understand their operational and compliance needs, translating them into robust validation strategies and practical, risk-based solutions. You will oversee end-to-end validation activities—ranging from planning and requirements analysis to testing, documentation, and release—while ensuring systems are audit-ready and compliant with global regulatory requirements.

Your key responsibilities

• Client Responsibilities
  • Participate and lead Regulatory Compliance engagements.
  • Help manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leaders.
  • Drive-in business development initiatives along with client management and account management.
  • Build strong internal relationships within Risk Consulting practice and with other services across the organization.
  • Build connects with client stakeholders, understand their business challenges/pain areas and work with leadership to propose innovative solutions.

• People Responsibilities
  • Develop people through effective coaching and mentoring.
  • Conduct performance reviews and contribute to performance feedback.
  • Contribute to people-related initiatives including recruiting, retaining, appraisal and training.
  • Contribute towards building and strengthening team competency for Regulatory Compliance and Risk consulting.
  • Participate in the organization-wide people initiatives.
  • Maintain an educational program to develop skills of team members continually.

• Decision-Making Responsibilities:
  • Support management in workforce planning, resourcing strategy, go to market strategy and demand generation.
  • Understand the business requirements clearly and lead practice development initiatives as required.
  • Bring out of the box thinking mindset, and analytical thinking capability to enhance service delivery.
  • Always maintain connections with clients to tap opportunities for constant growth and improvement.
  • Understand the process gaps and propose preventive/corrective action where appropriate.
  • Lead business growth, pursuits and client proposals for Enterprise Risk/Regulatory Compliance, directly working with the regional partners and senior managers.

Other Responsibilities

• Actively contribute to the IT applications project management initiatives that include Validation/Qualification/Variance Management activities as per GAMP Life Cycle approach.
• Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex or specialized issues in a regulatory environment. Work with clients to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement.
• Identify opportunities in existing accounts to cross-sell other EY services.
• Planning and monitoring of the project deliverables from the team.
• Create innovative insights for clients, adapt methods & practices to fit operational team needs & contribute to thought leadership documents.
• Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines.
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the clients business.
• Regular status reporting to the Associate Directors, Partners, Directors and onsite coordinators.
• Actively contributes to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Demonstrate flexibility to travel to the customer locations on need basis.
• Conduct performance reviews and contribute to performance feedback for staff, seniors and managers.
• Foster teamwork, quality culture and lead by example.
• Understand and follow workplace policies and procedures.
• Training and mentoring project resources.
• Participate in the organization-wide initiatives.
• Lead practice initiatives and portfolios.
• Market trend +Digital trends.
• Cross skill and cross train the team members as per the business requirements.

Skills and attributes for success

• Quality & Compliance managed services and Consulting experience in of Life Sciences Domain.
• Sound domain knowledge in pharmaceutical industry in the areas of Quality and Compliance
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems.
• Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11.
• Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
• Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.
• Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in pharmaceutical organization.
• Strong knowledge of Quality System Elements such as Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems.
• Strong understanding of Data Integrity requirements.
• Governance and reporting.
• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
• Strong Knowledge on authoring and reviewing Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
• Has supported Audits / Inspections.

To qualify for the role, you must have

• MBA/B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 13-16 years of experience with Big 4 or Multi-National Regulatory Compliance/Life Sciences outsourcing companies.
• Good interpersonal skills; Good written and presentational skills.
• At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations.
• Experience in managing team and solution designing.

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
• Project Management Professional (PMP)

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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