Senior Director, Quality Control & Inspection Readiness

BioSpace; Brisbane (CA); On-site; USD 280,000 - 320,000; Full time

Job summary

Nurix Therapeutics is seeking a Senior Director of Quality Control to establish and lead a QC function supporting programs from CMC development through commercial manufacturing. The role will manage internal staff and contract partners, drive QC strategy, and ensure product quality across the portfolio.

The candidate will oversee method validation, release and stability testing, and CAPA across CDMOs and CTLs, coordinate with Regulatory for submissions, and leader health authority inspections.

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, Chemical Engineering, or related discipline.
• BS/MS with 16+ years of relevant experience, or PhD with 14+ years of relevant experience.
• 5+ years in a QC leadership or management role with mentoring experience.
• Deep experience in small molecule pharmaceutical development including method lifecycle management and oversight of validation, release, and stability operations.
• Proven experience managing external manufacturing and testing operations at CDMOs and CTLs.
• Expertise with analytical methods such as HPLC, GC, dissolution, and microbiological testing.
• Direct experience leading through health authority inspections and internal audits; auditing GMP sites.
• Strong knowledge of cGMP, ICH guidelines, and USP/EP/JP standards.
• Experience contributing to global regulatory filings and health authority correspondence.
• Strong interpersonal and cross-functional collaboration skills.

Responsibilities

• Build and lead the QC function: establish QC systems and infrastructure; recruit, manage, and mentor internal QC staff and contractors.
• Set QC strategy across the product lifecycle: define and execute QC strategy from CMC development through commercial programs.
• Oversee QC operations internally and externally: direct method validation, release and stability testing, data review, deviations, investigations, change control, and CAPA at CDMOs and CTLs.
• Identify and manage quality risk: proactively manage risks related to patient safety, product quality, shelf life, supply continuity, or GMP compliance.
• Lead QC through audits and inspections: QC lead during health authority inspections and internal audits; audits of GMP sites including CDMOs and CTLs.
• Support regulatory submissions: contribute to global filings; respond to information requests and post-approval changes.
• Direct stability programs: develop stability strategy aligned with ICH and regional requirements.
• Manage reference materials and retention: qualify and inventory reference standards; sampling plans and retain programs.
• Drive continuous improvement: implement process improvements, data integrity enhancements, and eQMS upgrades.
• Travel up to 15% to CDMO, CTL, and manufacturing sites and conferences.

Skills

QC Leadership

Small Molecule Dev

Regulatory Inspections

Analytical Methods

Cross-functional Collaboration

Risk Management

Stability Testing

Quality Systems

Process Improvement

Education

Advanced degree in Chemistry/Pharmaceutics/Chemical Engineering

BS/MS or PhD with 14–16+ years experience

Job description

Nurix Therapeutics is seeking a Senior Director of Quality Control to establish and lead a QC function supporting programs from CMC development through commercial manufacturing. The role will manage internal staff and contract partners, drive QC strategy, and ensure product quality across the portfolio.

The candidate will oversee method validation, release and stability testing, and CAPA across CDMOs and CTLs, coordinate with Regulatory for submissions, and leader health authority inspections.