Business Consulting_Non FS Risk Transformation_Regulatory Compliance_Senior Manager
EY
- Bangalore, Karnataka
- Permanent
- Full-time
- 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
- 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
- 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.
- 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
- 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
- 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
- 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
- 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
- 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