Capricor Therapeutics, Inc. · 1 day ago
EQMS Business Analyst – Veeva Vault (Full Vault Implementation)
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $115K/yr
3+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking an experienced EQMS Business Analyst with specialized expertise in Veeva Vault to bridge business needs with system capabilities, ensuring compliant and efficient quality operations.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead or support end-to-end implementation of Veeva Vault Quality Suite, including requirements gathering, configuration, testing, validation, and go-live activities
Translate business needs into functional specifications and system design within Veeva Vault
Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles
Conduct detailed process mapping of current-state and future-state EQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training)
Facilitate workshops with cross-functional stakeholders to define requirements and align system capabilities with business objectives
Identify opportunities for process improvements and automation within Veeva
Support or lead system validation activities including user requirements (URS), functional specifications, IQ/OQ/PQ, and change control in compliance with GxP and 21 CFR Part 11
Ensure adherence to internal quality standards, regulatory expectations, and IT/CSV methodologies
Develop and execute test scripts, manage defects, and facilitate UAT sessions
Support go-live planning, cutover activities, and hypercare
Maintain updates to Veeva releases, including impact assessments and regression testing
Develop user training materials and deliver hands-on training for business end users
Provide ongoing support, troubleshoot issues, and manage enhancement requests
Serve as a subject matter expert (SME) for Veeva Vault within the Quality organization
Qualification
Required
3–7+ years of experience as a Business Analyst within Life Sciences Quality (Pharma, Biotech, Medical Devices)
Hands-on experience with full Veeva Vault implementation, preferably within the Vault Quality Suite (QualityDocs, QMS, Training)
Strong understanding of GxP, 21 CFR Part 11, Annex 11, and industry quality processes
Experience with system validation (CSV) and creating validation documentation
Excellent communication skills with the ability to translate technical concepts to non-technical users
Strong analytical, problem-solving, and stakeholder management skills
Preferred
Veeva Vault Administrator or Vault Quality certification(s)
Experience working with global teams and regulated environments
Familiarity with integration tools, APIs, and downstream/upstream system interfaces
Experience in managing enhancements post-implementation and supporting continuous improvement
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. 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
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
MarketScreener
2025-12-17
Genetic Engineering News
2025-12-09
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