Katalyst CRO ยท 3 months ago
Sr. Business System Analyst
Los Angeles, CA
Contract
Onsite
Senior LevelKatalyst Healthcares & Life Sciences is seeking an experienced Sr. Business System Analyst to lead and execute system validation and analysis initiatives within a regulated environment. The role involves developing and managing Veeva validation documentation, conducting gap analyses, and collaborating with global teams to ensure compliance and efficiency.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Ability to work independently and lead validation efforts end-to-end
Prior hands-on experience with CSA and GAMP 5 implementation projects
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
Preferred
Exposure to AI-driven business systems or OpenAI use cases
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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