Quality Systems Specialist (Veeva)
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. The Quality Systems Specialist (Veeva) is responsible for supporting Capricor's transition to the Veeva electronic Quality Management System (eQMS) and providing ongoing system administration, configuration, and maintenance. This role plays a key part in ensuring the eQMS meets GxP, regulatory, and operational requirements while enabling efficient and compliant quality processes. The Specialist will support implementation activities, system configuration, validation, user support, continuous improvement, and crossâfunctional collaboration. This is a highly visible role critical to Capricor's modernization of quality systems and digital infrastructure.
Requirements
- Bachelor's Degree and 5+ years of experience in a pharmaceutical, biologics, or FDAâregulated environment.
- Veeva Vault certifications (Administrator, Quality Suite) or equivalent handsâon experience administering and configuring Veeva Vault.
- Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMPâregulated environment.
- Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10.
- Experience supporting system implementation, validation, configuration, and release management activities.
- Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and nonâtechnical stakeholders.
- Proficiency with Microsoft Office applications.
Nice To Haves
- Experience migrating from a legacy QMS to Veeva Vault.
- Understanding of electronic signatures, data integrity principles, and audit trail requirements.
- Experience working with IT, Validation, and QA teams on system qualification activities.
- Prior involvement in developing SOPs, workflows, or training content for eQMS systems.
- Strong analytical and problemâsolving abilities with experience interpreting system metrics.
Responsibilities
- eQMS Transition & Implementation Coâlead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and goâlive readiness.
- Participate in system implementation activities including: Gathering and documenting user and business requirements (URS). Configuration of Veeva Vault Quality modules (QMS, Docs, Training). Data migration planning, mapping, execution, and verification.
- Coordinate and support system validation activities (IQ/OQ/UAT), including documentation and testing oversight.
- Support hypercare and postâimplementation stabilization activities.
- Collaborate with IT, Quality, Validation, and functional stakeholders to ensure alignment and readiness.
- System Setup & Configuration (Veeva Vault) Configure and maintain quality workflows, lifecycles, roles, permissions, and security settings.
- Manage configuration of Veeva processes including Deviations, CAPA, Change Control, Training, and Document Control.
- Maintain metadata structures, document hierarchies, and controlled vocabulary.
- Ensure system configuration aligns with regulatory expectations, internal SOPs, and data integrity standards.
- System Administration & Maintenance Serve as a Veeva eQMS System Administrator for Capricor.
- Support Veeva releases by performing impact assessments, regression testing, and required documentation updates.
- Manage system issues, enhancements, and change requests in partnership with Veeva Support.
- Create, update, and maintain system SOPs, work instructions, job aids, and system documentation.
- Continuous Improvement & Optimization Identify opportunities to enhance system usability, workflow efficiency, and user experience.
- Analyze system metrics (cycle times, overdue items, trending data) to drive optimization.
- Lead or support change management activities related to eQMS updates or process improvements.
- Training & User Support Conduct user training sessions, onboarding, and refresher training for Veeva Vault applications.
- Serve as a Veeva eQMS Subject Matter Expert (SME) to support end users with troubleshooting and best practices.
- Provide guidance on system usage to ensure compliance and data integrity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
