Quality Systems Specialist (Veeva)

Capricor Therapeutics • San Diego, CA

6d • $95,000 - $115,000

About The Position

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.

Requirements

• 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 technical and non‑technical stakeholders.
• Tools: 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 problem‑solving abilities with experience interpreting system metrics.

Responsibilities

• eQMS Transition & Implementation
• System Setup & Configuration (Veeva Vault)
• System Administration & Maintenance
• Continuous Improvement & Optimization
• Training & User Support

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees