[Remote] Director, GMP Quality Operations

Note: The job is a remote job and is open to candidates in USA. R1 Therapeutics is a California-based clinical-stage biotechnology company focused on transforming outcomes for patients with chronic kidney disease. The Director of GMP Quality Operations will provide strategic leadership for the GMP Quality function, ensuring product quality and compliance while overseeing quality for external partners and supporting the CKD portfolio from Phase 2b through commercialization.ResponsibilitiesLead the GMP Quality strategy and serve as the subject matter expert across drug substance, drug product, packaging, labeling, distribution, and stability, aligning quality activities with development milestones and future commercializationProvide quality oversight for CMOs, CDMOs, contract laboratories, suppliers, and other partners, including qualification, auditing, performance monitoring, quality agreements, and ongoing governance using a risk-based approachReview and approve GMP records and quality documentation, including batch records, deviations, investigations, CAPAs, change controls, specifications, protocols, reports, validation documents, and product release documentation, as applicablePartner with CMC, Technical Operations, Regulatory Affairs, and Supply Chain to support technology transfer, validation, process monitoring, comparability, lifecycle management, and uninterrupted clinical supplyLead inspection readiness and support regulatory inspections, partner audits, due diligence activities, and preparation of quality and CMC content for regulatory submissions and responsesAssess and escalate quality and compliance risks to leadership, providing clear, risk-based recommendations while fostering a culture of quality, compliance, and continuous improvementStay current with global GMP regulations and industry expectations, and proactively implement changes needed to maintain compliance and support commercial readinessSkillsBachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required; advanced degree preferred10+ years of progressive GMP Quality Assurance experience in biotechnology and/or pharmaceuticals, including support for clinical-stage development programsDemonstrated experience overseeing external manufacturing networks, including CMOs, CDMOs, contract laboratories, and critical suppliersStrong knowledge of global GMP and applicable GxP requirements, including FDA, EMA, and ICH guidanceDemonstrated experience leading GMP quality activities for small molecule products across the development lifecycle, with specific expertise in solid oral dosage form development, manufacturing and global regulatory complianceExperience leading or supporting regulatory inspections, supplier audits, due diligence, and review of GMP documentation, quality agreements, and regulatory submission contentAbility to apply science- and risk-based decision making to complex quality and compliance issues in a fast-paced environmentAbility to work effectively in a lean environment; hands-on, resourceful, and comfortable providing Quality input and building processes without well-established infrastructureAdvanced degree preferredExperience supporting investigational products from Phase 2 through Phase 3, with commercial readiness, process validation, and lifecycle management experience preferredExperience in small or emerging biotechnology companies preferred, along with strong communication skills and the ability to influence technical and executive stakeholdersCompany OverviewR1 Therapeutics is a clinical-stage biopharmaceutical company that develops first-in-class treatments for kidney disease patients. It was founded in 2026, and is headquartered in London, England, GBR, with a workforce of 2-10 employees. Its website is https://r1therapeutics.com.