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 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)

Qualifications

• 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, workstations, etc.) apply, and there is no anticipated work in a laboratory environment. This role is in office, hybrid, or remote, and a West Coast location/Pacific time zone is preferred. Car and/or airplane travel will be required of this role for work-related activities, conferences, and meetings. In addition, there is required travel to the office in South San Francisco, approximately every one to two months. Total travel is expected to be up to 25%. Advanced notice and travel support is provided.