Business Consulting_Non FS Risk Transformation_... @ EY
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Overview
At EY, you’ll have the chance to build a career as unique as you are. Join our EY Regulatory Compliance team to help clients navigate business needs and provide high quality, compliant solutions following EY guidelines and methodologies.
The Opportunity
This role is ideal for a Senior professional with expertise in Computer System Validation and stakeholder management. You will lead initiatives, drive project completions, and work cross-functionally while contributing to emerging service offerings.
Key Responsibilities
- Contribute to IT project management and Validation activities using GAMP Lifecycle approach.
- Integrate technology with business process transformation programs including SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault and others.
- Troubleshoot IT application issues and recommend effective solutions.
- Conduct gap assessments and remediation for legacy applications.
- Perform software classification, IT risk assessments, and mitigation strategies.
- Provide guidance on complex issues within a regulatory environment.
- Support business development on client engagements.
- Create innovative insights, adapt methodologies, and contribute to thought leadership.
- Mentor team members and ensure cross-skilling as per business requirements.
Skills and Attributes
To succeed, you need prior experience in leading quality and compliance projects in Regulatory Compliance, strong domain knowledge in the pharmaceutical industry, and expertise in computerized systems validation such as GAMP 5. Familiarity with regulations (USFDA, WHO, HIPAA, etc.), robust project management skills, and the ability to work collaboratively are essential.
Qualifications
- B.E/B.Tech or Postgraduate in Science with 5-8 years of relevant experience.
- Experience in Big 4 or Multi-National Regulatory Compliance companies.
- Certifications like CSQE, CSQA, ISO 9001:2015 Lead Auditor are a plus.
Working at EY
EY offers inspiring projects, access to coaching, career progression, and an interdisciplinary environment. Enjoy support, personalized development plans, and opportunities for growth in a global, market-leading firm.
Key skills/competency
Senior Regulatory Compliance Consultant; Computer System Validation; Stakeholder Management; GAMP 5; Pharmaceutical Compliance; IT Project Management; Risk Assessment; Quality Assurance; Cross-functional Teamwork; Regulatory Standards
How to Get Hired at EY
🎯 Tips for Getting Hired
- Tailor your resume: Highlight regulatory compliance successes and tech skills.
- Research EY: Understand their values and global initiatives.
- Prepare examples: Showcase project management in regulated environments.
- Network strategically: Connect with EY professionals on LinkedIn.
- Practice interview insights: Emphasize stakeholder management and compliance expertise.