RC-REGULATORY COMPLIANCE-BA-Manager

EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager - Business Analyst (Life Sciences IT Systems)

The opportunity

We are seeking an experienced Manager Business Analyst with strong consulting skills and domain expertise in Life Sciences IT systems to lead regulatory clinical safety lab and manufacturing-related technology implementations. This role combines process expertise solutioning delivery leadership and stakeholder engagement to drive successful outcomes in regulated GxP environments.

Role Overview

As a Manager you will own client relationships lead teams of analysts and ensure high-quality delivery of IT implementation projects. You will guide requirements definition process optimization validation planning and data migration/integration strategies while also supporting senior leadership in client pursuits and RFP responses. This role demands strong consulting acumen ability to manage complex programs and a focus on operational excellence

Your key responsibilities

• Lead end-to-end delivery of Business Analysis workstreams across regulatory/ clinical/ safety/ lab/ manufacturing IT systems.
• Drive solutioning activities ensuring alignment of technology capabilities with business objectives and compliance requirements.
• Provide process expertise across Life Sciences business processes including R&D Clinical Regulatory and Quality workflows and translate these into system requirements.
• Lead workshops for as-is/to-be analysis workflow design and data mapping between legacy and new systems.
• Oversee data migration and system integration planning ensuring alignment with business processes and compliance requirements.
• Provide strategic guidance on validation planning and execution including authoring and reviewing documentation (Validation Plan URS FRS IQ/OQ/PQ Validation Report).
• Manage requirement traceability and testing governance using tools like JIRA Confluence qTest and ALM.
• Develop dashboards and reporting frameworks for project performance risks and compliance tracking.
• Act as a trusted advisor to clients ensuring stakeholder alignment and managing expectations at senior leadership levels.
• Mentor and coach junior team members fostering a culture of collaboration and continuous improvement.
• Support business development initiatives by assisting with client pursuits drafting RFP responses and delivering impactful presentations in collaboration with senior leadership.
• Contribute to thought leadership and internal capability-building initiatives within the Regulatory Compliance practice.

Qualifications:

• Bachelors degree in computer science Information Technology Life Sciences or a related field advanced degree preferred.
• 8-12 years of experience as a Business Analyst in IT projects within regulated environments with at least 35 years in a leadership capacity.
• Strong understanding of Life Sciences business processes in R&D/ Clinical/ Regulatory/ Quality/ Safety domains and ability to map these into technology solutions.
• Proven experience managing large-scale IT implementation projects in Life Sciences (Regulatory Safety Clinical LIMS ERP MES etc.).
• Strong understanding of SDLC Agile methodologies and GxP compliance frameworks.
• Expertise in CSV/CSA methodologies validation planning and audit readiness.
• Exceptional communication stakeholder management and client engagement skills.

Must-Have Skills & Attributes

• Deep knowledge of GAMP 5 SDLC and validation best practices.
• Ability to lead complex workshops for requirements process design and data migration mapping.
• Strong proficiency in requirements and testing tools (JIRA Confluence qTest ALM) and dashboard/reporting solutions.
• Experience in system integration planning and business process alignment.
• Demonstrated success in client-facing roles managing senior stakeholders and delivering strategic solutions.
• Strong leadership skills with experience in mentoring and team development.
• Ability to troubleshoot issues manage risks and drive resolution in high-pressure environments.
• Familiarity with change control deviation handling and CAPA processes
• Experience in IT project management and governance
• PMP/CSQA Certification

Good-to-Have Skills & Attributes

• Exposure to business development activities including client pursuits and RFP support.
• Familiarity with regulatory compliance frameworks (FDA EMA) and audit remediation.
• Experience in process optimization and operational efficiency initiatives.
• Ability to align technology with business transformation goals
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

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

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 around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way thats right for you