Sr. Manager, GxP Auditor (GCP & GMP)

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. Summary The Associate Director, Vendor Management and Audits is a senior leader within the Quality Assurance organization responsible for defining and executing Kyverna’s global GxP vendor management process and audit strategy across clinical, pharmacovigilance, and manufacturing operations. This role provides strategic oversight of the internal audit program, vendor quality management, vendor product recall, and inspection readiness, ensuring alignment with global regulatory expectations and organizational priorities. The Associate Director will lead the evolution of a scalable, risk-based vendor management and compliance framework, both external and internal, to support Kyverna’s expanding pipeline and global footprint, while serving as a key advisor to senior leadership on quality, compliance risks, and mitigation strategies. Location: Remote (West Coast hours preferred) Reports to: Sr Dir Quality Compliance, GCP & Risk Management Travel: Willingness to travel up to 25% Responsibilities Evolve and lead the global GxP audit strategy across GCP, GMP, and GPV domains, ensuring alignment with regulatory requirements and business objectives Oversee and execute high-risk and complex internal and external audits, including CROs, CDMOs, and critical vendors, with accountability for audit outcomes and CAPA effectiveness Provide strategic leadership in the design, implementation, and continuous improvement of a scalable, risk-based internal audit program Serve as a subject matter expert and advisor to senior leadership on GxP compliance risks, audit findings, and inspection readiness strategy Support, as directed, operationalizing inspection readiness procedures, mock audits, and assure closure of identified continuous improvement opportunities from outcomes Act as primary Quality Vendor Mgmt./Audits process representative during regulatory inspections, supporting interactions with Health Authorities and ensuring timely and accurate responses Oversee the global supplier quality and vendor management program, including qualification, performance monitoring, and risk-based oversight Drive quality improvement initiatives to strengthen compliance frameworks and audit operational effectiveness Establish commercial Product Recall process, collaborating with CDMO(s) and potential vendor service Lead the development, review, and governance of SOPs, policies, and quality standards to ensure alignment with evolving regulatory expectations, guiding audit strategies Partner cross-functionally with QA Operations, Manufacturing, Patient Operations, External Vendors, and PV/Safety function to establish and operationalize commercial Product Complaint process Develop and mentor Kyverna SME guest audit capability Influence and shape quality strategy in a fast-paced, build-phase environment, ensuring sustainability and scalability of systems and processes Qualifications ASQ Certified Quality Auditor (CQA) or equivalent certification required BA/BS in Biological Sciences, Chemistry, or related field (advanced degree preferred) 12+ years of experience in the pharmaceutical or biotechnology industry, including 7+ years in GxP auditing (GCP, GMP, GPV) Deep expertise in global regulatory requirements (FDA, EMA, ICH guidelines) and inspection management Demonstrated leadership experience with direct people management and/or program leadership at scale Proven ability to influence cross-functional stakeholders and drive strategic initiatives Strong communication skills, including the ability to present complex issues to senior leadership Experience operating in high-growth, clinical-stage or commercializing biotech environments Experience in cell and/or gene therapy Strong background in risk-based quality systems and audit program design Direct experience leading regulatory inspections and managing Health Authority interactions Advanced proficiency with eQMS and clinical systems (e.g., Veeva Vault, RIM, Argus, Medidata) Demonstrated ability to build and scale quality infrastructure in a growing organization Willingness to travel up to 25% The national base salary range for this position is $170K-$195K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company’s stock plan. #J-18808-Ljbffr Kyverna Therapeutics