Regulatory Compliance Senior - Enterprise Risk - Global Delivery Services

at  EY

EY - GDS CONSULTING - ENTERPRISE RISK (ER) - REGULATORY COMPLIANCE - SENIOR

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior 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 and lead internal initiatives.

THE OPPORTUNITY

We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join 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.

SKILLS AND ATTRIBUTES FOR SUCCESS

• Prior experience of leading quality and compliance projects in Regulatory Compliance.
• Sound domain knowledge in pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance.
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems.
• Hands on experience of preparing validation deliverables for software implementation projects.
• Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11.
• Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa, etc.
• Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC.
• 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.
• Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report, etc.
• Demonstrated track record in project management, governance, and reporting.
• Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls, etc.
• Exposure to Data Integrity requirements and other applicable regulations.
• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
• Prior experience of supporting Audits / Inspections.

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.
• Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
• 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.
• 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.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Contribute to performance feedback for staff.
• Foster teamwork and a positive learning culture.
• Understand and follow workplace policies and procedures.
• Training and mentoring of project resources.
• Cross skill and cross train the team members as per the business requirements.

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 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies.
• Good interpersonal skills.
• Good written, oral and presentation skills.