Job Details

Job Description:
We are seeking an experienced Sr. Business System Analyst to lead and execute system validation and analysis initiatives within a regulated environment. The ideal candidate will have strong experience with CSA and GAMP 5 methodologies, along with deep expertise in Veeva validation management.
Responsibilities:

• Lead and execute system analysis and validation efforts following CSA and GAMP 5 principles.
• Develop and manage Veeva validation documentation including requirements, test scripts, traceability matrices, and risk assessments.
• Collaborate with global and virtual teams to define system requirements and drive successful implementation.
• Conduct gap analyses, identify risks, and propose mitigation strategies to ensure compliance and efficiency.
• Partner with IT, Quality, and Business stakeholders to align technical solutions with business needs.
• Serve as a subject matter expert in system validation, mentoring project teams.
• Manage multiple concurrent initiatives ensuring timely delivery and adherence to regulatory standards.
• Support process improvement initiatives to enhance compliance and system reliability.

• Proven experience implementing CSA and GAMP 5 frameworks.
• Strong knowledge of Veeva validation management and basic understanding of Veeva configurations.
• Excellent analytical, problem-solving, and communication skills.
• Experience collaborating with global, cross-functional teams.
• bility to work independently and lead validation efforts end-to-end.
• Prior hands-on experience with CSA and GAMP 5 implementation projects.
• Exposure to AI-driven business systems or OpenAI use cases.
• Proven track record of managing multiple priorities under tight timelines.
• Strong presentation and stakeholder management skills.
• Experience working with Product Owners, Service Owners, and QA teams to ensure compliant, high-quality deliveries.