Sr. Business System Analyst
Katalyst Healthcares and Life SciencesSan Francisco, CA, United States17 hours ago
Job type
- Full-time
Job descriptionProven 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.
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.
Requirements :
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System Analyst • San Francisco, CA, United States
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