Senior Director, Quality Control

Job description

**Senior Director, Quality Control** *Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a* *new script to outmatch disease.* **Position Description** Nurix Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical Development and Quality Control group. This individual will establish and lead a QC operational function, establishing operations, systems, and a team to support programs from CMC development through commercial manufacturing. The ideal candidate brings deep expertise in small molecule QC, strong regulatory acumen, and proven experience managing external CDMO and CTL relationships. This role will represent QC in health authority inspections and audits, and will work cross-functionally with Quality, Analytical Development, and Manufacturing to ensure product quality and patient safety across the portfolio. **Key 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 escalate 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 **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 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 **Fit with Nurix Culture and Values** - Strong team orientation; highly collaborative - Solutions and results-oriented focus - Hands-on approach; resourceful and open to diverse points of view **Salary Range:**$280,200 - $319,800 **Location:** Woodlands TX or Brisbane, CA - Onsite