Similar Jobs
See allMember of Compliance & Risk, Testing and Monitoring
Anchorage Digital
US
IT Risk
Auditing
GRC
Sr. Manager, GxP Auditor (GCP & GMP)
Kyverna Therapeutics
US
GMP
GCP
Veeva Development Cloud Manager
Sobi
Europe
GxP
System Administration
Solution Design
Director Business Operations
TrustYou
Europe
Business Operations
IT Operations
SaaS
Clinical Research Associate
Kyverna Therapeutics
US
Clinical Operations
Site Management
FDA Regulations
Responsibilities:
- Execute validation for GxP systems using CSA, authoring validation plans, risk assessments, and test protocols.
- Manage system lifecycle activities, ensuring documentation is inspection-ready and aligned with regulatory standards.
- Partner with IT and business stakeholders for system onboarding, change control, and vendor assessments.
Compliance and Oversight:
- Lead validation for platforms like Veeva Vault, ensuring compliance with 21 CFR Part 11 and EU Annex 11.
- Perform supplier system assessments and maintain oversight to meet internal and regulatory standards.
- Support audits and inspections, proactively identifying and remediating compliance gaps.
Collaboration and Improvement:
- Act as the primary IT partner to Quality for validation, data integrity, and compliance activities.
- Collaborate cross-functionally with Quality, Clinical, and Regulatory to align on strategy and governance.
- Support development of validation procedures and provide training on requirements and best practices.
Kyverna Therapeutics
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The company is guided by core values including collaboration and innovation, operating in a fast-paced, regulated environment committed to transforming autoimmune disease treatment.