Sr. Business System Analyst

4 days ago

Los Angeles, CA, United States Katalyst Healthcares and Life Sciences Full time
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:
  • 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.

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