Senior Manager, External Quality-Supply Chain
About The Position
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 Nurix’s 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.
Requirements
- Bachelor’s 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
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
