Trackwise Consultant - Senior

As a Regulatory Compliance Senior Consultant TrackWise at EY, your role involves understanding clients' business needs and delivering solutions in line with EY guidelines and methodologies. You will actively establish, maintain, and strengthen internal and external relationships, ensuring high-quality project completion and operational efficiency. Your responsibilities include proactively identifying and addressing risks, leading internal initiatives, and collaborating with the client and EY senior management team. Role Overview: - Deliver end-to-end TrackWise Digital implementations, including requirements gathering, solution design, configuration, and testing. - Work closely with client stakeholders to translate business needs into compliant system solutions. - Develop GxP documentation, conduct system demos, and ensure high-quality delivery aligned with regulatory standards. - Contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes. Key Responsibilities: Client Responsibilities: - Collaborate with client stakeholders to understand business requirements and translate them into user stories. - Develop functional specifications and technical designs aligned with requirements. - Configure, build, and deploy TrackWise Digital solutions based on approved designs. - Conduct system demos, support testing activities, and prepare GxP-compliant documentation. - Ensure solution design and delivery adhere to quality and regulatory requirements in Life Sciences environments. Skills and Attributes for Success: - Ability to translate business needs into system designs. - Hands-on, solution-oriented mindset with attention to quality and compliance. - Strong communication skills to engage with cross-functional stakeholders. - Detail-oriented approach in regulated environments. - Understanding of GxP regulations and quality expectations. - Effective contributor in project-based delivery. Qualifications: - Bachelor's degree in computer science or related field. - Minimum of 5 years of experience as a TrackWise/Quality Systems Consultant. - Experience in GxP-regulated environments and knowledge of drug safety regulations. - Detail-oriented with excellent organizational skills. - Strong communication skills and proficiency in analytical reporting tools. Must-Have Skills and Attributes: - Hands-on experience with TrackWise Digital. - Experience with quality systems and validation requirements. - TrackWise Digital Certification and Salesforce Certification. - Proficiency in GxP documentation and system integration. - Strong analytical and problems-solving skills. - Commitment to patient safety and data confidentiality. Good-to-Have Skills & Attributes: - Experience in Agile delivery models. - Exposure to risk management and compliance readiness activities. - Familiarity with CI/CD toolsets and enterprise integration landscapes. - Client-facing experience involving requirement walkthroughs. At EY, you will have the opportunity to work with a diverse team of professionals and contribute to impactful quality transformation initiatives. You will receive support, coaching, and feedback while having the flexibility to shape your role according to your preferences. EY is dedicated to building a better working world by creating new value for clients, society, and the planet through innovative solutions and trusted partnerships. As a Regulatory Compliance Senior Consultant TrackWise at EY, your role involves understanding clients' business needs and delivering solutions in line with EY guidelines and methodologies. You will actively establish, maintain, and strengthen internal and external relationships, ensuring high-quality project completion and operational efficiency. Your responsibilities include proactively identifying and addressing risks, leading internal initiatives, and collaborating with the client and EY senior management team. Role Overview: - Deliver end-to-end TrackWise Digital implementations, including requirements gathering, solution design, configuration, and testing. - Work closely with client stakeholders to translate business needs into compliant system solutions. - Develop GxP documentation, conduct system demos, and ensure high-quality delivery aligned with regulatory standards. - Contribute to project execution within agile delivery teams, supporting testing, defect resolution, and continuous improvement across quality processes. Key Responsibilities: Client Responsibilities: - Collaborate with client stakeholders to understand business requirements and translate them into user stories. - Develop functional specifications and technical designs aligned with requirements. - Configure, build, and deploy TrackWise Digital solutions based on approved designs. - Conduct system demos, support testing activities, and prepare GxP-compliant documentation. - Ensure solution design and d