FDA 21 CFR

Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition). Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models. Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports. Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design. Experience managing system change control and periodic review programs for validated GxP systems. Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team. Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders. Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment. Preferred Qualifications Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation. Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context. Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert. Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements. Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants. Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2). Advanced degree in a relevant scientific, engineering, or regulatory discipline. Fit with Nurix Culture and Values You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism — You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes . You own the program — You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location:

Brisbane, CA

Onsite Salary Ranges:
Senior Manager, CSA(Quality)
$170,538
$193,493 Associate Director, CSA(Quality)
$190,269
$216,360 Nurix Therapeutics, Inc.

is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( https://www.nurixtx.com/privacy-policy/) . Company Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Company info Website https:

//www.nurixtx.com/ Phone 415-660-5320 Location 1700 Owens Street Suite 205 San Francisco California 94158 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. 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Associate Director, Computer Systems Assurance (Quality)