The Role
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 Veeva Vault EQMS Specialist with deep expertise in Veeva Vault, ideally someone who has led or played a key role in full implementations across QualityDocs, QMS, Training, and other Vault Quality modules. This role will partner closely with Quality and cross‑functional teams to translate business needs into scalable system design, ensuring that our Veeva ecosystem supports compliant, efficient, and future‑ready quality operations.
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.
- Testing & Deployment
- 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.
- Training & Support
- 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.
Requirements:
- 3+ years of experience as a Business Analyst in Life Sciences Quality (Pharma, Biotech, or Medical Devices).
- Hands-on experience with full Veeva Vault implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training).
- Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes.
- Experience with computer system validation (CSV) and creation of validation documentation.
- Excellent communication skills with the ability to translate technical concepts for non-technical audiences.
- Strong analytical, problem‑solving, and stakeholder management capabilities.
- Must be able to work on site Monday to Friday.
Preferred Qualifications:
- Veeva Vault Administrator or Vault Quality certification.
- 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.
Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
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The Company
What We Do
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of cell and exosome-based therapeutics. Its lead product candidate, Deramiocel, is an allogeneic cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). The company also leverages its proprietary StealthX™ exosome platform for the targeted delivery of therapeutic agents to treat a wide range of diseases.
