Senior Director, Quality Control: Strategy & Compliance

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

Job summary

Nurix Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical Development and Quality Control group. This leader will establish and run a QC function, creating systems, infrastructure, and a team to support programs from CMC development through commercial manufacturing.

The ideal candidate will bring deep small-molecule QC expertise, strong regulatory acumen, and a track record managing external CDMO and CTL partnerships, with responsibility for inspections

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, Chemical Engineering, or related discipline.
• 5+ years in a QC leadership or management role, with demonstrated ability to build and mentor teams
• 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 and conducting audits of manufacturing and testing sites.
• Deep working knowledge of cGMP, ICH guidelines, and USP/EP/JP compendial standards
• Experience contributing to global regulatory filings and health authority correspondence (e.g., responses to information requests, post-approval changes)
• Strong interpersonal and cross-functional collaboration skills, with the ability to influence and build consensus across Quality, Supply Chain, Analytical Development, and Manufacturing functions

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 spanning CMC development through commercial programs, ensuring alignment with company milestones and submission timelines
• Oversee QC operations internally and externally: Direct method validation, release and stability testing, data review, deviations, investigations, change control, and CAPA internally and at CDMOs, and CTLs
• Identify and manage quality risk: Proactively identify, assess, and elevate risks related to patient safety, product quality, shelf life, supply continuity, or GMP compliance; drive risk mitigation strategies in partnership with Analytical Development, Quality, and Manufacturing functions
• Lead QC through audits and inspections: Serve as QC lead during health authority inspections and internal audits; collaborate with Quality to conduct audits of GMP manufacturing and testing sites, including CDMOs and CTLs
• Support regulatory submissions and health authority interactions: Contribute to global regulatory filings; collaborate on responses to health authority information requests, regulatory commitments, and post-approval changes
• Direct stability programs: Develop and execute stability strategy in collaboration with Analytical Development leads, ensuring alignment with ICH guidelines and regional regulatory requirements
• Manage reference materials and retains: Oversee qualification and inventory of reference standards; develop sampling plans and manage sample retain programs
• Drive continuous improvement: Identify and implement process improvements, data integrity enhancements, and quality system upgrades (e.g., eQMS) to support a scalable, inspection-ready QC organization
• Travel up to 15% to CDMO, CTL, and manufacturing sites and supplier and scientific conferences

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Vendor/CDMO management

Education

Advanced degree in Chemistry, Pharmaceutics, Chemical Engineering, or related discipline

BS/MS with 16+ years of relevant experience, or PhD with 14+ years

Tools

HPLC

GC

Dissolution

Microbiological testing

Job description

Nurix Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical Development and Quality Control group. This leader will establish and run a QC function, creating systems, infrastructure, and a team to support programs from CMC development through commercial manufacturing.

The ideal candidate will bring deep small-molecule QC expertise, strong regulatory acumen, and a track record managing external CDMO and CTL partnerships, with responsibility for inspections