Director, Quality Systems
Nkarta is a publicly traded (Nasdaq symbol NKTX), South San
Francisco headquartered, early-stage biopharmaceutical company
focused on the discovery, development and commercialization of
allogeneic, off-the-shelf engineered natural killer, or NK, cell
therapies to treat cancer.
Founded in 2015 at the birthplace of biotechnology, our
development pipeline of engineered NK cell therapy candidates
includes two co-lead clinical programs, NKX101 and NKX019. Clinical
trials for 101 are in process; 019 will begin in H2 2021. Nkarta
recently announced a collaboration with CRISPR Therapeutics, a
world leader in gene-based medicines, for the development and
commercialization of up to three new cell therapy candidates and
access to clinically validated CRISPR/Cas9 genome engineering.
Complementing our broad research and development capabilities,
Nkarta has also built an extensive cell therapy manufacturing
operation. We have a 2,700-square foot clinical good manufacturing
practice, or cGMP, facility on-site at our primary corporate
location in South San Francisco, California. We plan to start
in-house manufacturing of NKX019 in 2021 and NKX101 in 2022. We are
also currently designing a separate, larger cGMP facility, to
supply our anticipated pivotal clinical trial and commercial
Position Title Director, Quality Systems
Location South San Francisco
Reports to Head of Quality
This role is responsible for the promotion and applied
integration of quality awareness and continuous improvement within
Nkarta's broad manufacturing organization which includes internal
capabilities as well as external collaborators. The role includes
accountability for all quality systems and the implementation of
policies and procedures that meet or exceed internal and external
requirements. The position is a key member of the Quality
leadership team and is responsible for helping to lead teams in an
integrated way that supports the delivery of our business
- Provides leadership and strategic direction for Nkarta's
- Ensures that adequate personnel are available to perform the
quality system oversight.
- Hires, trains, mentors, and develops staff to ensure continuity
of the Quality function.
- Develops and implements Nkarta's Quality Management System
(QMS) in accordance with applicable regulatory guidelines and
appropriately maintain and roll out the QMS, including but not
o An appropriate documentation and records management system
o An effective training system (Training)
o Process for deviation investigations, corrective action, and
preventive action (Deviations, Investigations, and CAPA)
o A process for investigating and tracking quality related
o Process for managing changes (Change Control)
o Systems for maintaining and calibrating critical equipment
(Preventive Maintenance and Calibration)
o Equipment qualification program (Validation)
o A system for reviewing incoming materials and suppliers of
those materials (Supplier Quality)
o A stability program to support retest or expiry dates and
storage conditions on APIs, drug substance, drug product, and/or
intermediates where appropriate
o A process for review and managing risks (Risk Management)
o A process for review and continuous improvement of the QMS
o An internal and external audit system exists (Audits and
o Quality Manual
- Liaises with Product Development, Manufacturing,
Engineering/Maintenance, and other areas, as required, to ensure
that quality systems are appropriately implemented.
- Establishes strong relationships with internal and external
collaborators to build, enhance and ensure quality awareness.
- Collaborates with all departments to ensure that quality
standards and GxP compliance are met and maintained.
- Oversees internal and external audit programs that focus on GMP
compliance, regulatory agency inspection readiness, and for cause
- Provides technical support for validation content. Reviews and
approves equipment, facility, and computerized system qualification
- Develops and monitors appropriate metrics to track quality and
- Ensures inspection readiness.
- Performs product quality reviews.
- Strong knowledge of GMP regulations and experience with
regulatory compliance inspections.
- Strong knowledge and experience with 21CFR11, 21CFR210,
21CFR211, ICH Q7, ICH Q8, PIC/S, Eudralex Volume 4 as well as other
international regulations. Knowledge of 21CFR1271 and 21CFR610 are
- Ability to apply principles of logical and scientific thinking
to a wide range of intellectual and practical problems.
- Independence and creative problem-solving abilities; comfort
working in the fluid structure of start-up biotech. Integrity,
confidence, passion, and collaborative spirit will be highly
- Ability to effectively lead teams and manage staff.
- Strong verbal and written communication skills to communicate
effectively with groups and individuals; ability to respond.
- Embodies the Nkarta culture of empowerment, diversity, and
- Ability to achieve operational excellence in a new environment
and with new technology area (NK cells).
- Bachelor's degree in Biology, Chemistry, Life Science, or
Engineering is required; advanced degree is preferred
- 15+ years of experience in the pharmaceutical/biotechnology
- 10+ years of GMP QA/QC experience.
- 10+ years management experience.
- Previous experience in GMP manufacturing of cell therapy or
biological products is required. Experience working with CMOs is
preferred. Experience with both clinical and commercial products is
Specific vision abilities for this job include close vision,
depth perception, and ability to adjust focus. The role may require
on rare occasion the ability to work in an aseptic, gowned
environment for brief periods of time. The common requirements of
an office environment (computers, computer screens, workstations,
etc.) apply when not working in or around the laboratory
The 100+ 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 in which we're working, here are real
anonymous comments of why people think Nkarta is a great place to
- People are always open to ideas. This company provides a safe
place for its employees (covid testing, etc.)
- Exceptionally talented, committed, kind & supportive
- 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
- 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