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Director, Quality Systems

Company: Nkarta, Inc.
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

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 needs.

Position Title Director, Quality Systems

Location South San Francisco

Reports to Head of Quality

Position Summary

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 goals.

Key Responsibilities

  • Provides leadership and strategic direction for Nkarta's quality systems.
  • 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 limited to:

o An appropriate documentation and records management system (Document Control)

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 complaints (Complaint)

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 (Management Review)

o An internal and external audit system exists (Audits and Inspections)

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 audits.
  • Provides technical support for validation content. Reviews and approves equipment, facility, and computerized system qualification protocols.
  • Develops and monitors appropriate metrics to track quality and process improvement.
  • Ensures inspection readiness.
  • Performs product quality reviews.

Position Requirements

  • 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 a plus.
  • 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 valued.
  • 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 inclusion.
  • Ability to achieve operational excellence in a new environment and with new technology area (NK cells).

Education /Experience

  • Bachelor's degree in Biology, Chemistry, Life Science, or Engineering is required; advanced degree is preferred
  • 15+ years of experience in the pharmaceutical/biotechnology industry.
  • 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 preferred.

Working Environment

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 environment.

About Nkarta

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 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

Keywords: Nkarta, Inc., South San Francisco , Director, Quality Systems, Other , South San Francisco, California

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