EQMS Business Analyst Veeva Vault (Full Vault Implementation)
About The Position
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX⢠exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. We are seeking an experienced EQMS Business Analyst with specialized expertise in Veeva Vault , preferably someone who has led or played a key role in full Vault implementations (QualityDocs, QMS, Training, and other Vault Quality modules) . The ideal candidate will bridge business needs with system capabilities, ensuring that our Veeva ecosystem supports compliant, efficient, and scalable quality operations.
Requirements
- 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
101-250 employees
