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 - Enterprise Risk (ER) - Regulatory Compliance - Associate DirectorAs part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Associate Director 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, identify automation opportunities and drive internal initiatives.The opportunityWe\'re looking for Associate Director with expertise in Life Sciences Regulatory Compliance and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.Your key responsibilitiesClient 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 connect 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 Associate Directors.

Other Responsibilities

• Actively contribute to the IT applications project management initiatives that includes 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 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
• 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 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 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
• 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

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 offersAt 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 worldEY 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.

EY