Job
Description
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting –Tech Consulting – Veeva SMR & LS Practice Lead – Senior Manager As part of our EY-Technology Consulting team, you will help the clients by understanding their business needs and translating their strategies into realities through innovation. You will be also responsible for building a 10-15 member Veeva LS Team in GDS, and run the practice As a Veeva SMR actively establish, maintain and strengthen internal and external relationships. In line with our commitment to digital transformation, 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, identify automation opportunities and drive internal initiatives. Your Key Responsibilities Client Responsibilities Participate and lead Veeva engagements in the area of GxP, Non-GxP and commercial.Responsible for building a 10-15 member Veeva LS Team in GDS, and run the practiceHelp manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leadersDrive-in business development initiatives along with client management and account managementBuild strong internal relationships within Technology Consulting practice and with other services across the organizationBuild connect with client stakeholders, understand their business challenges/pain areas and work with leadership to propose innovative solutions People Responsibilities Develop Veeva people/practice through effective coaching and mentoringConduct performance reviews and contribute to performance feedbackContribute to people-related initiatives including recruiting, retaining, appraisal and trainingContribute towards building and strengthening team competency for Veeva deployments including Business Process Analysis, Configurations and data migrationParticipate in the organization-wide people initiativesMaintain an educational program to develop veeva skills of team members continually Decision-Making Responsibilities: Support management in workforce planning, resourcing strategy, go to market strategy and demand generationUnderstand the business requirements clearly and lead practice development initiatives as requiredBring out of the box thinking mindset, and analytical thinking capability to enhance service deliveryAlways maintain connections with clients to tap opportunities for constant growth and improvementUnderstand the process gaps and propose preventive/corrective action where appropriateLead business growth, pursuits and client proposals for Veeva opportunities (RFPs and RFIs), directly working with the regional partners and Associate Directors. Other Responsibilities Actively contribute to the IT applications project management initiatives that includes project planning, risk assessment, business process analysis, test and data migration strategy as per GAMP Life Cycle approachIntegrate technology with business process transformation programs in quality and regulatory space covering Quality Management, Change Management, regulatory Information management, LIMS with Veeva suite of products like RIMS, QMS, Quality Docs, CTMS etc.Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagementSound understanding of the Veeva suite of products in GxP and commercial including integrations, configuration management, operational compliance, data migration etc.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, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelinesMaintain 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 client's business.Regular status reporting to the Associate Directors, Partners, Directors and onsite coordinators.Actively contribute 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 basisConduct performance reviews and contribute to performance feedback for staff, senior and managersFoster teamwork, quality culture and lead by exampleUnderstand and follow workplace policies and proceduresTraining and mentoring of project resourcesParticipate in the organization-wide initiativesLead practice initiatives and portfoliosMarket 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 along with Veeva products in the areas of Quality and ComplianceStrong knowledge of regulatory processes in clinical, laboratory and digital quality along with understanding of GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized SystemsStrong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts.Strong Knowledge on Veeva products like Veeva QMS, Vault Quality Docs, RIMS, CTMS with key focus on OOB functionalities, custom configurations and data migration.Strong knowledge on Veeva custom configuration and migration techniques.Strong understanding of Data Integrity requirementsGovernance and reportingKnowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.Knowledge on operational compliance for Cloud Applications like Veeva.Strong Knowledge on authoring and review of 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 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance/Life Sciences outsourcing companiesGood interpersonal skills; Good written and presentational skillsAt managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.
