Director, Quality Management Systems
Company: Nurix Therapeutics
Location: Brisbane
Posted on: April 5, 2026
|
|
|
Job Description:
Director, Quality Management Systems Nurix Therapeutics is a
clinical-stage biopharmaceutical company focused on the discovery,
development, and commercialization of targeted protein degradation
therapeutics. Leveraging our proprietary DELigase platform, we
design small molecules that harness the body’s own protein disposal
system to selectively eliminate disease-causing proteins. Our
pipeline spans oncology and immune-mediated diseases, and our team
is united by a commitment to scientific excellence and meaningful
impact for patients. We are a team of scientists, innovators, and
problem-solvers committed to improving patient lives. We value
integrity in everything we do — from the bench to the boardroom —
and we foster an environment where every voice is heard and every
contribution matters. Position The Director, Quality Management
Systems is a newly created leadership role designed to address a
critical need at Nurix Therapeutics. As the company advances its
pipeline and scales its development operations, the need for a
robust, efficient, and compliant Pharmaceutical Quality Management
System (PQMS) infrastructure has never been greater. This role will
own the strategy and execution of PQMS oversight across the
organization, with a specific mandate to remediate and optimize the
current Veeva Vault implementation, validate critical quality
systems, and elevate the overall capabilities of the QMS team. The
Director will assess the current state of QMS operations, develop a
prioritized improvement roadmap, and lead the upskilling of
existing staff to meet late pivotal phase clinical operations and
commercial industry standards. This is a high-visibility,
high-impact role reporting directly to the Head of Quality, with
cross-functional accountability across Quality, IT, CMC, and
Regulatory Affairs Responsibilites Own and lead the Quality
Management Systems function, including document control, Training,
Deviation/CAPA, and Change Control. Conduct a comprehensive
assessment of the current PQMS and develop and execute a
remediation plan to address inefficiencies, workflow gaps, and
compliance deficiencies to include implementation of validated
systems and the use of AI tools. Partner with IT to establish a
Computer System Assurance (CSA) program for critical quality
systems, ensuring compliance with 21 CFR Part 11, Annex 11, PIC/s,
and applicable guidance. Partner with IT to define eQMS system
requirements, manage system validation activities, and ensure
appropriate data integrity controls are in place Define and
implement PQMS performance metrics and KPIs; present trends and
improvement initiatives to Quality leadership and cross-functional
stakeholders Develop and execute a capability-building strategy for
the QMS team, including structured onboarding, training programs,
performance coaching, and clear competency standards Serve as the
QMS subject matter expert during regulatory inspections and
internal audits; support inspection readiness activities and manage
observation responses Collaborate with Quality Operations,
Regulatory Affairs, and Manufacturing to ensure QMS processes are
integrated into day-to-day GMP operations and support pipeline
milestones Drive standardization and continuous improvement of
quality processes and procedures across the organization Manage and
develop a team of QMS staff and contractors; provide mentorship,
clear direction, and accountability for deliverables Maintain
current knowledge of regulatory expectations for quality systems,
data integrity, and GxP compliance; translate requirements into
practical operational guidance Develop a regulatory intelligence
solution for Nurix. Qualifications Bachelor’s degree in life
sciences, engineering, information systems, or a related field;
advanced degree preferred 10 years of progressive quality systems
experience in the pharmaceutical or biopharmaceutical industry; or
8 years with a relevant advanced degree Demonstrated hands-on
experience with Veeva Vault QMS, including system configuration,
workflow design, and remediation or optimization initiatives
Experience in computer system validation (CSV), 21 CFR Part 11, and
GxP data integrity requirements Proven track record leading QMS
infrastructure improvements in a clinical-stage or commercial
biotech/pharma environment Knowledge of FDA and ICH GMP regulations
(21 CFR Parts 210/211, Q8, Q9, Q10) and their practical application
within PQMS frameworks Experience managing, developing, and
upskilling quality teams; demonstrated ability to build
organizational capability Exceptional communication and stakeholder
management skills, including experience presenting to senior
leadership and interacting with regulatory agency representatives
Strategic thinker with strong operational execution skills;
comfortable managing multiple high-priority initiatives
simultaneously Preferred Qualifications Experience in a
clinical-stage biotech company scaling QMS operations through
pipeline advancement and potential commercialization Familiarity
with small molecule and/or biologic drug development quality
requirements Experience partnering with IT and validation teams on
system implementation projects. Prior experience supporting FDA,
EMA, or other regulatory agency inspections as QMS lead Fit with
Nurix Culture and Values You lead with integrity and set the
standard — you bring the same rigor and accountability to quality
systems that our scientists bring to the bench You are a builder
who thrives in ambiguity, energized by the opportunity to shape
something meaningful from the ground up in a high-growth
environment You invest in people — you know that sustainable
quality outcomes depend on capable, engaged teams, and you take
developing others as seriously as you take system compliance Salary
Range: $211,698 - $243,384 plus bonus and equity Location:
Brisbane, CA – Onsite Nurix Therapeutics, Inc. is committed to
protecting and respecting your privacy and personal information,
including information collected by Nurix when you apply for a job
with Nurix or in the course of your employment with Nurix. By
applying for a position at Nurix, you agree to our collection and
use of personal information as described in our Privacy Policy (
https://www.nurixtx.com/privacy-policy/) . Applicants must be
legally authorized to work for any employer in the United States.
Note to Employment Agencies: Please do not forward any agency
resumes. Nurix will not be responsible for fees related to
unsolicited resumes.
Keywords: Nurix Therapeutics, Novato , Director, Quality Management Systems, Science, Research & Development , Brisbane, California