At EY youll 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 were 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 Senior Manager
As 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 Senior Manager actively establish maintain and strengthen internal and external line with our commitment to quality youll 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 opportunity
Were looking for Senior Manager 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 responsibilities
Client 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 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 Regulatory Compliance and Risk consultingParticipate in the organization-wide people initiativesMaintain an educational program to develop skills of team members continuallyDecision-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 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 approachIntegrate 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 engagementIdentify 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 clients 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 requirementsSkills 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 ComplianceStrong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized SystemsStrong knowledge of standards such as USFDA 21 CFR Part 11 EU GMP Annex 11Strong 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 Pharmaceutical organization.Strong knowledge of Quality System Elements such as Deviation CAPA and Change Controls etc. as they relate to Computer SystemsStrong understanding of Data Integrity requirementsGovernance and reportingKnowledge 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 / InspectionsTo qualify for the role you must have
MBA / B.E / (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 organizationsExperience in managing team and solution designingIdeally youll 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 certificationsProject ManagementWhat 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 offers
At EY were dedicated to helping our clients from startups 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 aroundOpportunities to develop new skills and progress your careerThe freedom and flexibility to handle your role in a way thats right for youEY 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.
Required Experience :
Senior Manager
Key Skills
Compliance Management,Risk Management,Financial Services,PCI,Banking,Cost Accounting Standards,Quality Systems,Research Experience,NIST Standards,Securities Law,SOX,ISO 27000
Employment Type : Full Time
Experience : years
Vacancy : 1
