DE-ET-Veeva life sciences tech lead-GDSN

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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 practice
• 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 Technology Consulting practice and with other services across the organization
• Build 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 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 Veeva deployments including Business Process Analysis, Configurations and data migration
• Participate in the organization-wide people initiatives
• Maintain 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 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 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 approach
• Integrate 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 engagement
• Sound 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 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 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 basis
• Conduct performance reviews and contribute to performance feedback for staff, senior and managers
• Foster teamwork, quality culture and lead by example
• Understand and follow workplace policies and procedures
• Training and mentoring of 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 along with Veeva products in the areas of Quality and Compliance
• Strong knowledge of regulatory processes in clinical, laboratory and digital quality along with understanding of 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,
• 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 requirements
• Governance and reporting
• Knowledge 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 companies
• Good interpersonal skills; Good written and presentational skills
• At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations

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