RC-REGULATORY COMPLIANCE-Trackwise Consultant-Senior Full Time NEW

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Join EY and help to build a better working world.

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Consultant– TrackWise

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 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 an experienced and detail‑oriented TrackWise Consultant to support the design, configuration, and implementation of TrackWise Digital Quality Management solutions for Life Sciences clients. This role is critical in enabling compliant, efficient, and scalable quality processes within GxP‑regulated environments. If you have strong hands‑on experience with TrackWise Digital, a solid understanding of quality and validation requirements, and enjoy working in agile, project‑based delivery models, this opportunity offers an excellent platform to contribute to impactful quality transformation initiatives.

Role Overview

As a TrackWise Consultant, you will be responsible for delivering end-to-end TrackWise Digital implementations, from requirements gathering and solution design through configuration and testing. You will work closely with client business, IT, and quality stakeholders to translate business needs into compliant system solutions. The role involves developing GxP documentation, supporting validation activities (IQ/OQ/PQ), conducting system demos, and ensuring high-quality delivery aligned with regulatory and quality standards. You will also contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes.

Your Key Responsibilities

Client Responsibilities

• Collaborate with client business and IT stakeholders to understand business requirements and translate them into clear user stories
• Develop functional specifications and technical designs aligned to defined requirements
• Configure, build, and deploy TrackWise Digital solutions based on approved technical designs
• Conduct system demos and playback sessions with client business and IT teams
• Perform system configuration testing, support code reviews, and manage merges
• Support creation, execution, and defect resolution for User Acceptance Testing (UAT) and validation testing (IQ/OQ/PQ)
• Prepare, review, and maintain GxP‑compliant documentation, including functional specifications, configuration documents, and validation artifacts
• Ensure solution design and delivery adhere to quality and regulatory requirements in regulated Life Sciences environments
• Support project management activities including task tracking, status reporting, risk/issue management, and delivery coordination

Skills And Attributes For Success

• Strong ability to translate business needs into functional and technical system designs
• Hands‑on, solution‑oriented mindset with attention to quality and compliance
• Ability to work effectively in Agile teams and contribute within CI/CD environments
• Strong communication skills to engage with cross‑functional business and IT stakeholders
• Structured and detail‑oriented approach, especially in regulated GxP environments
• Strong understanding of GxP regulations and quality expectations for computerized systems
• Ability to balance technical delivery with quality and compliance requirements
• Effective contributor in project‑based delivery, with the ability to manage priorities, timelines, and dependencies

Qualifications

• Bachelor’s degree in computer science, Electrical/Electronic Engineering, Information Technology, or a related field (or equivalent)
• Minimum of 5+ years of relevant experience as a TrackWise / Quality Systems Consultant.
• Experience working in GxP‑regulated Life Sciences environments with exposure to quality systems
• Knowledge of global drug safety regulations including FDA, EMA, ICH guidelines.
• Detail-oriented with excellent data entry and organizational skills.
• Ability to work independently and as part of a team in a fast-paced, regulated environment.
• Strong communication skills to interact effectively with internal teams and external stakeholders.
• Proficiency for dashboard and PV related analytical reports creation using Power BI and similar tools
• Willingness to work flexible hours or shifts if required.

Must-Have Skills And Attributes

• Hands‑on experience configuring and implementing TrackWise Digital – Quality Management System in the Life Sciences industry
• Experience implementing one or more TrackWise Digital modules such as Platform, EQMS, Complaints, SQM
• Experience with Change Control module (preferred within must‑have scope)
• TrackWise Digital Certification
• Salesforce Certification (Admin / Platform App Builder / Platform Developer)
• Experience developing GxP documentation such as functional/configuration specifications and test scripts (IQ/OQ/PQ)
• Experience integrating TrackWise Digital with enterprise systems (SAP, CRM, Data Warehouse, etc.).
• Collaborate with cross-functional teams including IT, Quality Assurance, and Pharmacovigilance to identify system requirements, troubleshoot issues, and support system upgrades and enhancements throughout the product lifecycle.
• Strong understanding of quality systems and validation lifecycle for regulated applications
• Proven experience supporting project execution, including coordination across business, IT, and quality stakeholders
• Strong analytical and problem-solving skills to identify and resolve data discrepancies.
• Commitment to maintaining patient safety and data confidentiality.
• Excellent time management skills to meet strict reporting deadlines.

Good-to-Have Skills & Attributes

• Prior experience working in Agile delivery models
• Prior experience supporting regulated system implementation projects with formal project management governance
• Exposure to risk management, issue tracking, and compliance readiness activities
• Familiarity with CI/CD toolsets and continuous delivery practices
• Exposure to multi‑system enterprise integration landscapes
• Experience in client‑facing roles involving demos, playbacks, and requirement walkthroughs.

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.