Senior Director/Executive Director, Head of GCP Quality Assurance

About the role

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. 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 through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
• Manage health authority inspection preparation activities and provide leadership and oversight during inspections
• Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
• Compile and analyze audit metrics to communicate trends to business groups
• Maintains a high level of expertise in GCP drug development regulations, ICH guidelines and internal policies and procedures that may impact drug development.
• Conduct GCP training sessions for business groups
• Build out the GCP function to support pivotal readiness
• Manage direct reports (if applicable)

Requirements

• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
• Direct/lead experience with FDA, EMA, MHRA, PMDA, or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
• Fundamental knowledge of US, EU and APAC international regulatory standards and guidelines for the conduct of clinical trials.
• Strong analytical skills and report writing skills.
• Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines.
• Excellent teamwork skills with the ability to develop and maintain positive, collaborative relationships with colleagues at all levels across the organization.
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
• Experience with supervising direct reports preferred.
• Education/Background
• Bachelor's degree in science-related discipline with advanced degree preferred.
• Preferably 15+ years' experience in Clinical research/ operations/data management or related area. Minimum of 8 years of Clinical Quality Assurance auditing
• Cell/Gene therapy experience desired but not required.
• The common requirements of an office environment (computers, computer screens, workstati

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