Quality Systems Specialist (Veeva)

Role Summary

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 ensures 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.

Responsibilities

• eQMS Transition & Implementation: Co‑lead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and go‑live readiness
• eQMS Transition & Implementation: Participate in system implementation activities including gathering and documenting user and business requirements (URS)
• eQMS Transition & Implementation: Configuration of Veeva Vault Quality modules (QMS, Docs, Training)
• eQMS Transition & Implementation: Data migration planning, mapping, execution, and verification
• eQMS Transition & Implementation: Coordinate and support system validation activities (IQ/OQ/UAT), including documentation and testing oversight
• eQMS Transition & Implementation: Support hypercare and post‑implementation stabilization activities
• eQMS Transition & Implementation: Collaborate with IT, Quality, Validation, and functional stakeholders to ensure alignment and readiness

Responsibilities

• System Setup & Configuration (Veeva Vault): Configure and maintain quality workflows, lifecycles, roles, permissions, and security settings
• System Setup & Configuration (Veeva Vault): Manage configuration of Veeva processes including Deviations, CAPA, Change Control, Training, and Document Control
• System Setup & Configuration (Veeva Vault): Maintain metadata structures, document hierarchies, and controlled vocabulary
• System Setup & Configuration (Veeva Vault): Ensure system configuration aligns with regulatory expectations, internal SOPs, and data integrity standards

Responsibilities

• System Administration & Maintenance: Serve as a Veeva eQMS System Administrator for Capricor
• System Administration & Maintenance: Support Veeva releases by performing impact assessments, regression testing, and required documentation updates
• System Administration & Maintenance: Manage system issues, enhancements, and change requests in partnership with Veeva Support
• System Administration & Maintenance: Create, update, and maintain system SOPs, work instructions, job aids, and system documentation

Responsibilities

• Continuous Improvement & Optimization: Identify opportunities to enhance system usability, workflow efficiency, and user experience
• Continuous Improvement & Optimization: Analyze system metrics (cycle times, overdue items, trending data) to drive optimization
• Continuous Improvement & Optimization: Lead or support change management activities related to eQMS updates or process improvements

Responsibilities

• Training & User Support: Conduct user training sessions, onboarding, and refresher training for Veeva Vault applications
• Training & User Support: Serve as a Veeva eQMS Subject Matter Expert (SME) to support end users with troubleshooting and best practices
• Training & User Support: Provide guidance on system usage to ensure compliance and data integrity

Qualifications

• Required: Education & Experience: Bachelor's Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment
• Required: Certification: Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault
• Required: Quality Background: Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated environment
• Required: Regulatory Knowledge: Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10
• Required: Technical Skills: Experience supporting system implementation, validation, configuration, and release management activities
• Required: Soft Skills: Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non‑technical stakeholders
• Required: Tools: Proficiency with Microsoft Office applications
• Preferred: Experience migrating from a legacy QMS to Veeva Vault
• Preferred: Understanding of electronic signatures, data integrity principles, and audit trail requirements
• Preferred: Experience working with IT, Validation, and QA teams on system qualification activities
• Preferred: Prior involvement in developing SOPs, workflows, or training content for eQMS systems
• Preferred: Strong analytical and problem‑solving abilities with experience interpreting system metrics

Additional Requirements

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