Associate Director/Director, GCP Quality Assurance

Nkarta is a publicly traded (Nasdaq symbol NKTX), biotechnology company headquartered in South San Francisco focused on the discovery, development and manufacturing of off-the-shelf, natural killer (NK) cell therapies. Our near-term goal is to bring cell therapy out into the community setting, dramatically expanding access for patients. 

Founded in 2015 at the birthplace of biotechnology, Nkarta is a fast-growing, fast-moving, clinical-stage company that has built an extensive cell therapy manufacturing operation in anticipation of product commercialization. Our developmental pipeline of engineered NK cell therapies includes clinical programs in B-cell malignancies and autoimmune diseases.

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation.  We recently built out a 23,000-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California.

Nkarta is a people-driven company looking for passionate, collaborative, driven team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.  

The Associate Director/Director, 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 of 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.

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.

• 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
• Manage direct reports (if applicable)

• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
• Direct/lead experience with FDA, EMA, MHRA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
• Fundamental knowledge of US, EU and 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 10+ years’ experience in Clinical research/ operations/data management or related area. Minimum of 6 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 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.

A reasonable estimate of the current salary range for this position is $176,000 - $230,000.  There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education and experience, as well as the value of other elements of an employee’s total compensation package.  Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans.  Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.

The 150+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.

• “People are always open to ideas. This company provides a safe place for its employees (covid testing, etc.)”
• “Exceptionally talented, committed, *kind* & supportive team.”
• “The CEO is transparent and honest with expectations for the whole company. There is genuine care amongst the leadership team for their peers and employees. I believe this is unique.”
• “Not to sound corny, but the emphasis on people as a valuable resource is something I recognize doesn't often exist elsewhere, and it's here in ample supply, which is great.”
• “It's the first place that I've worked where the executive team truly values the employees. It's a pretty amazing thing not to hear that employees can be replaced with someone new. Institutional knowledge is understood.”
• “We have a very diverse team with executives that are friendly and accessible.”
• “Smart and dedicated colleagues. Mission to make a difference in patients’ lives. Empower us with tools needed to succeed. Open and transparent culture. Transparent leadership. Handling of covid and running the company was done very well.”

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company’s website at https://www.nkartatx.com.