$250K — $500K+*
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.
· 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).
· 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.
Valid through: 4/10/2021
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