Quality Systems Specialist; Veeva

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 Stealth

X™ 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 cross‑functional collaboration. This is a highly visible role critical to Capricor’s modernization of quality systems and digital infrastructure.

• Co‑lead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and go‑live 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 post‑implementation stabilization activities.
• Collaborate with IT, Quality, Validation, and functional stakeholders to ensure alignment and readiness.

• Configure and maintain quality workflows, life cycles, 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.

• 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.

• 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.

• 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.

• Education & Experience: Bachelor’s Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment.
• Certification: Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault.
• Quality Background: Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated environment.
• Regulatory Knowledge: Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10.
• Technical
  
  Skills:
  
  Experience supporting system implementation, validation, configuration, and release management activities.
• Soft Skills: Strong documentation, organization, and communication skills; ability to collaborate effectively with…