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
- 3â7+ 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
