Senior Director, GMP Quality Assurance | Late-Stage

Regulatory Jobs; Brisbane (CA); On-site; USD 228,000 - 252,000; Full time

Job summary

Nurix Therapeutics is seeking a Director of Quality Assurance to lead GMP QA for small molecule CMC programs and serve as the primary interface with CDMOs. You will be accountable for the quality and timely supply of clinical materials, and for inspection readiness while building and mentoring the QA team as we advance toward commercialization.

Reporting to the Senior Vice President of Quality, you will provide strategic leadership across QA, CMC, and Regulatory Affairs, ensuring FDA/ICH/GMP

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or related field.
• 12+ years of progressive QA experience with formal leadership.
• Deep GMP expertise for small molecule drug substances and products.
• Experience managing CDMOs and external labs for QA.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211) and ICH/GMP.
• Proven CAPA, deviation, change control experience in clinical or commercial settings.
• Experience supporting regulatory inspections (FDA, EMA, or equivalent).
• Proven ability to lead, develop, and motivate QA teams.
• Excellent project management and organizational skills.
• Strong written and verbal communication; able to present to executives.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead GMP QA for small molecule CMC programs and CDMO interfaces.
• Ensure quality and timely supply of clinical materials and inspection readiness.
• Build, mentor, and develop the QA team for pipeline support.
• Oversee deviations, investigations, batch records, lot disposition, reports, specs.
• Lead regulatory filings support and partner with Regulatory Affairs on timelines.
• Support eQMS implementation and system improvements.
• Maintain knowledge of evolving regulatory expectations and translate to operations.

Skills

QA Leadership

GMP Expertise

CDMO Management

Regulatory Knowledge (FDA/ICH)

CAPA / Change Control

Inspections Experience

Cross-functional Collaboration

Project Management

Communication Skills

Travel Readiness

Education

Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or related field

Tools

eQMS (e.g., Veeva Vault)

Job description

Nurix Therapeutics is seeking a Director of Quality Assurance to lead GMP QA for small molecule CMC programs and serve as the primary interface with CDMOs. You will be accountable for the quality and timely supply of clinical materials, and for inspection readiness while building and mentoring the QA team as we advance toward commercialization.

Reporting to the Senior Vice President of Quality, you will provide strategic leadership across QA, CMC, and Regulatory Affairs, ensuring FDA/ICH/GMP