Senior Director, Clinical Quality Assurance

Artiva Biotherapeutics • San Diego, CA

7d • $220,000 - $270,000 • Remote

About The Position

The Senior Director, Clinical Quality Assurance provides strategic leadership and operational oversight of Artiva’s GCP/GVP quality programs to ensure compliance across global late‑phase clinical trials. This leader ensures the organization is ready for inspections, implements and manages risk-based quality systems, collaborates across departments to advance development programs, and prepares the team for BLA/BIMO milestone achievements. This role requires an experienced Clin QA Senior leader who can build high‑performing teams, influence in a matrixed environment, and anticipate and respond to evolving regulatory expectations. This position is part of the senior quality team responsible for overall Quality culture and continuous improvement of Artiva’s QMS and compliance.​​

Requirements

• BS or BA in a scientific discipline required.
• 12+ years of US/EU Clinical QA experience in biologics or pharmaceuticals.
• 5+ years of leadership/supervisory experience.
• Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits.
• Expert knowledge of global GCP/GVP regulations including:
• CLIA, CLIP, CAP
• 21 CFR Parts 11, 50, 54, 56, 312, 320, 812
• ICH E6(R2/R3), ICH E8
• EU CTR 536/2014, GDPR
• Annex 11, Annex 13, ATMP Regulation 1394/2007
• Deep understanding of QA expectations for cell therapy clinical trials.
• High proficiency in Microsoft Word, Project, Visio, Excel, and Smartsheet.
• Demonstrated success leading teams and initiatives in a matrixed environment.
• Strong strategic thinking, communication, collaboration, and decision‑making skills.
• Ability to influence senior stakeholders and external partners.

Nice To Haves

• Experience in cell therapy and autoimmune programs preferred.
• Commercialization experience a plus.

Responsibilities

• Strategic Leadership & Governance
• Develop and execute a clinical QA strategic vision aligned to business and program objectives.
• Establish and track goals, budgets, headcount plans, and performance metrics for the Clinical QA function.
• Provide thought leadership by anticipating regulatory changes, industry trends, and evolving GCP/GVP expectations.
• Serve as the senior Clin QA representative on program teams, sub‑teams, and study teams.
• Clinical Quality System Ownership & Compliance Oversight
• Ensure all GCP/GVP activities meet global regulatory, quality, and compliance standards for late‑phase clinical trials.
• Oversee the development, implementation, and continuous improvement of clinical quality systems, processes, SOPs, and governance structures and ensure appropriate division and touchpoints with GMP.
• Lead creation and execution of a harmonized GCP/GVP SOP roadmap, collaborating closely with Clinical Development and external partners.
• Audit & Inspection Management
• Lead the design and execution of a risk‑based GCP/GVP audit program covering internal audits, vendor audits, and clinical site audits (routine and for‑cause).
• Assess audit findings for impact on subject safety, data integrity, and business operations, and ensure timely CAPA development and closure.
• Lead GCP inspection readiness initiatives, including mock BIMO interviews, inspection preparedness plans, and cross‑functional training.
• Manage BIMO sponsor inspections and provide oversight/support for CRO inspections.
• Cross‑Functional Collaboration
• Partner with Clinical Operations, Medical Affairs, Pharmacovigilance and Safety, Regulatory Affairs, Biometrics, Data Management, CROs, vendors, and clinical sites to ensure operational compliance.
• Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, BLAs, and other submission‑related materials.
• Oversee compliance activities associated with contract laboratories supporting clinical studies.
• Risk Management & Issue Resolution
• Implement and maintain a risk‑based GCP/GVP oversight strategy encompassing trial conduct, site compliance, data integrity, and safety reporting.
• Support investigations of site deviations, protocol noncompliance, and GCP violations, ensuring thorough root cause analysis, CAPA effectiveness, and proper documentation.
• Identify and escalate compliance risks, recommending mitigation plans to Clinical Development and Quality leadership.
• Training & Organizational Readiness
• Lead or oversee annual GCP training programs across the organization.
• Communicate regulatory changes, best practices, and compliance expectations to internal stakeholders.
• Supervisory Responsibilities
• Lead, mentor, and develop Clinical QA personnel, promoting a culture of accountability, collaboration, and continuous improvement.

Benefits

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

What This Job Offers

• Job Type: Full-time
• Career Level: Director