EY RC-Non FS Risk Transformation-Regulatory Compliance-Manager 

India, West Bengal, Kolkata 

823267651

Your key responsibilities

• Actively contribute to the IT applications project management initiatives that includes Validation 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.
• Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
• Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
• 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
• Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
• 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 Senior Managers, 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 and senior staff
• 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
• Has worked in executing the Validation Deliverables in software implementation projects
• 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.
• Versed with SOP documentation, analysing the work instructions, user manuals
• 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

• 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 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

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 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.