Senior Director/Executive Director, Head of GCP Quality Assurance

About Us Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease. Founded in 2015, Nkarta is on a mission to harness the body’s natural killer cells – the immune system’s first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings. Nkarta’s engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand. Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.    Overview The Senior Director / Executive Director, Head of GCP Quality Assurance oversees GCP activities at Nkarta, our CROs and Investigator Sites, leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization by Health Authorities for our cellular therapy drug candidates, which are predominantly CAR-NK cell-based. This person will manage cross- functional relationships with internal and external stakeholders and be the Lead Clinical Quality Assurance representative to clinical teams. In addition, the Head of GCP Quality Assurance will build out the GCP quality assurance function at Nkarta, as we advance our lead candidate toward potentially pivotal trial(s) in 2027. With a strong focus on translating groundbreaking research into transformative therapies, we are driven by a passion for improving patient outcomes and addressing unmet medical needs. Our dynamic team combines expertise from both large pharmaceutical companies and agile biotech startups, fostering a collaborative environment where individual contributions are valued and innovation thrives. Responsibilities Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits Author and manage Audit Plans and Audit reports Facilitate ongoing quality improvement thr...