Quality Systems Specialist (Veeva) jobs in United States
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Capricor Therapeutics, Inc. · 2 weeks ago

Quality Systems Specialist (Veeva)

positionSan Diego, CA
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$95K/yr - $115K/yr
date5+ years exp

Capricor Therapeutics is a biotechnology company focused on advancing innovative therapies for rare diseases. The Quality Systems Specialist (Veeva) will support the transition to a Veeva electronic Quality Management System, ensuring compliance with regulatory standards and optimizing quality processes.

BiotechnologyHealth CareMedicalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

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, 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
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

Qualification

Veeva VaultQuality AssuranceGxP regulationsSystem implementationRegulatory knowledgeAnalytical skillsMicrosoft OfficeDocumentation skillsOrganizational skillsCommunication skillsProblem-solving skills

Required

Bachelor's Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment
Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault
Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated 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 non‑technical stakeholders
Proficiency with Microsoft Office applications

Preferred

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

Company

Capricor Therapeutics, Inc.

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Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
dateFounded in 2005
location
Los Angeles, California, USA
people-size51-200 employees
web-link
http://www.capricor.com

H1B Sponsorship

Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$329.5M
Key Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M

Leadership Team

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AJ Bergmann
Chief Financial Officer
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Company data provided by crunchbase