Senior Manager, External Quality-Supply Chain
Brisbane, CA - USA
Job Summary
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 Nurixs 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 medicines next chapter with a new script to outmatch disease.
The Senior Manager Supply Chain Quality Assurance is responsible for ensuring the quality and compliance of materials products and distribution activities throughout the global supply chain. This position provides quality oversight of contract manufacturers suppliers warehouses packaging operations depots and logistics providers to ensure compliance with applicable GMP GDP GCP (where applicable) and company quality standards.
This role partners with Supply Chain Manufacturing Regulatory Affairs Technical Operations Clinical CMC and external business partners ensuring the quality compliance and timely supply of clinical materials across Nurixs pipeline programs.
Reporting to the Senior Director Quality Assurance the Senior Manager will apply sound independent judgment to drive timely identification investigation and resolution of quality events while building a culture of continuous improvement and cross-functional collaboration.
- Provide Quality oversight of global supply chain operations supporting early and late-stage clinical programs.
- Ensure quality requirements are incorporated into procurement manufacturing packaging storage transportation and distribution activities.
- Oversee quality aspects of warehousing and distribution operations.
- Qualify monitor and maintain approval status of suppliers CMOs laboratories depots and logistics providers.
- Participate in supplier audits and quality risk assessments.
- Manager supplier quality agreements and ensure periodic review.
- Ensure compliance with Good Distribution Practices.
- Oversee qualification of shipping lanes and transportation providers.
- Review shipping validation documentation.
- Assess quality impact of shipping deviations through the review of shipping deviations including review of temperature excursion investigations and product impact assessments.
- Identify continuous improvement opportunities to simply quality processes while maintaining compliance.
- Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.
- Bachelors degree in chemistry pharmaceutical sciences life sciences engineering or a related
- 5 years of progressive Supply Chain or Supply Chain Quality Assurance experience in the pharmaceutical or biopharmaceutical industry with global distribution activities.
- Demonstrated experience managing and directing activities of outsourced manufacturing testing packaging and labeling and distribution operations.
- Thorough knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q7 Q8 Q9 Q10 Q11) and EudraLex - Volume 4 - Good Manufacturing Practice (GMP) and their practical application to CMC development.
- Proven track record managing quality events deviations CAPA programs and change control in a clinical or commercial pharmaceutical setting.
- Experience supporting regulatory agency inspections (FDA EMA or equivalent).
- Excellent project management skills with the ability to manage multiple high-priority deliverables simultaneously.
- Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders.
- Willingness to travel to CDMO and laboratory sites domestically and internationally as
- Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
- Experience with electronic QMS platforms (e.g. Veeva Vault) and document management
- Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.
Salary: $173000 - $19900
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
Required Experience:
Senior Manager