R1 Therapeutics is a California-based (with presence in North Carolina and Boston) clinical-stage biotechnology company dedicated to transforming outcomes for patients living with chronic kidney disease. R1 is building a portfolio of differentiated therapies to address the interconnected complications of CKD—starting with hyperphosphatemia, where unmet need remains high and the standard of care has gone largely unchanged for decades.

The company’s lead asset, AP306, a small molecule, is a first-in-class pan phosphate transporter inhibitor with Phase 2a proof-of-concept and the potential to deliver meaningfully better efficacy with a lower pill burden. R1 launched in 2026 with a $77.5M Series A backed by Abingworth, F-Prime Capital, DaVita Venture Group, and U.S. Renal Care, and is advancing AP306 into Phase 2b with topline data expected in 2027

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Position Descripti

onThe Director, GMP Quality Operations provides strategic and operational leadership for R1 Therapeutics’ GMP Quality function, ensuring product quality, compliance, and continuous improvement across clinical development and preparation for commercialization. This role serves as the GMP Quality subject matter expert and establishes phase-appropriate quality systems to support the CKD portfolio from Phase 2b through Phase 3 and commercial readines

s.
In a fast-paced, collaborative biotech environment, this leader oversees quality for CMOs, CDMOs, testing laboratories, suppliers, and strategic partners, and partners closely with CMC, Clinical Operations, Regulatory Affairs, Supply Chain, and executive leadership. The role applies science- and risk-based decision making to ensure GMP compliance, product quality, patient safety, data integrity, and inspection readiness across AP306 and future pipeline programs. This position reports to the VP, Quali

ty.
While this role can be based anywhere in the US, preference will be given to candidates in either the San Francisco Bay Area or the Raleigh-Durham, NC A

rea.
Key Responsibil

• itiesLead 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 commercializa
• tion.Provide 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 appr
• oach.Review 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 applic
• able.Partner with CMC, Technical Operations, Regulatory Affairs, and Supply Chain to support technology transfer, validation, process monitoring, comparability, lifecycle management, and uninterrupted clinical su
• pply.Lead inspection readiness and support regulatory inspections, partner audits, due diligence activities, and preparation of quality and CMC content for regulatory submissions and respo
• nses.Assess and escalate quality and compliance risks to leadership, providing clear, risk-based recommendations while fostering a culture of quality, compliance, and continuous improve
• ment.Stay current with global GMP regulations and industry expectations, and proactively implement changes needed to maintain compliance and support commercial readi

ness.
Education and Experience Requir

• ementsBachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required; advanced degree pref
• erred.10+ years of progressive GMP Quality Assurance experience in biotechnology and/or pharmaceuticals, including support for clinical-stage development pro
• grams.Demonstrated experience overseeing external manufacturing networks, including CMOs, CDMOs, contract laboratories, and critical supp
• liers.Strong knowledge of global GMP and applicable GxP requirements, including FDA, EMA, and ICH gui
• dance.Demonstrated 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 compl
• iance.Experience supporting investigational products from Phase 2 through Phase 3, with commercial readiness, process validation, and lifecycle management experience pref
• erred.Experience leading or supporting regulatory inspections, supplier audits, due diligence, and review of GMP documentation, quality agreements, and regulatory submission co
• ntent.Ability to apply science- and risk-based decision making to complex quality and compliance issues in a fast-paced enviro
• nment.Experience in small or emerging biotechnology companies preferred, along with strong communication skills and the ability to influence technical and executive stakeho
• lders.Ability to work effectively in a lean environment; hands-on, resourceful, and comfortable providing Quality input and building processes without well-established infrastru

cture.
Why

• Join R1Opportunity to shape the strategy of a company redefining treatment for kidney
• diseaseHighly visible role with direct impact on company direction and
• growthCollaborative, mission-driven culture with a focus on innovation and
• urgencyAbility to work at the forefront of science while driving meaningful business o

utcomes