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

Responsibilities:
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eQMS Transition & Implementation
• 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.

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.

Required Skills:
• 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.

Preferred / Nice-to-Have Skills:
• 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.

Work Environment / Physical Demands:
• Primarily office‑based with extensive computer use for system configuration, documentation, and administration.
• Ability to sit for extended periods while working on system or documentation tasks.
• Occasional lifting of materials up to 15 pounds.
• Ability to move between office and operational areas to support cross‑functional needs.

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.