Director, GMP Quality Operations

Company overview

R1 Therapeutics is a California-headquartered clinical-stage biotechnology company with operations in North Carolina and Boston. Its mission is to improve outcomes for people living with chronic kidney disease by developing differentiated therapies for the complications associated with CKD. The company’s first focus is hyperphosphatemia, an area where treatment options have changed very little for many years despite substantial unmet need.

The lead program, AP306, is a small-molecule, first-in-class pan phosphate transporter inhibitor. It has already shown proof of concept in Phase 2a and is being developed to deliver stronger efficacy with fewer pills. R1 launched in 2026 with a $77.5M Series A supported by Abingworth, F-Prime Capital, DaVita Venture Group, and U.S. Renal Care, and is moving AP306 into Phase 2b with topline results anticipated in 2027.

Role summary

The Director, GMP Quality Operations will provide both strategic direction and day-to-day leadership for the GMP Quality function at R1 Therapeutics. The role is responsible for ensuring product quality, regulatory compliance, and ongoing improvement across clinical development activities and the path to commercialization.

This leader acts as the internal subject matter expert for GMP Quality and helps establish fit-for-phase quality systems to support the company’s CKD portfolio from Phase 2b through Phase 3 and into commercial readiness. The position requires close collaboration with CMC, Clinical Operations, Regulatory Affairs, Supply Chain, executive leadership, and external partners. Decisions should be grounded in science and risk, with a strong focus on GMP compliance, patient safety, data integrity, and inspection readiness across AP306 and future pipeline assets. This role reports to the VP, Quality.

The role may be based anywhere in the United States, though candidates in the San Francisco Bay Area or the Raleigh-Durham, North Carolina area are preferred.

Key responsibilities

• Define and lead the GMP Quality strategy, acting as the primary quality expert across drug substance, drug product, packaging, labeling, distribution, and stability activities while keeping quality plans aligned with development timelines and future commercialization.
• Oversee quality management of CMOs, CDMOs, contract testing laboratories, suppliers, and other external partners through qualification, audits, performance tracking, quality agreements, and ongoing governance using a risk-based approach.
• Review and approve GMP documentation and quality records, including batch records, deviations, investigations, CAPAs, change controls, specifications, protocols, reports, validation packages, and product release materials, as appropriate.
• Work closely with CMC, Technical Operations, Regulatory Affairs, and Supply Chain teams to support technology transfer, validation, process monitoring, comparability, lifecycle management, and continuity of clinical supply.
• Drive inspection readiness and support regulatory inspections, partner audits, due diligence efforts, and the preparation of quality and CMC sections for regulatory filings and responses.
• Identify, assess, and elevate quality and compliance risks to leadership, offering clear recommendations based on scientific and risk-based judgment while strengthening a culture of quality and continuous improvement.
• Keep up to date with global GMP requirements and industry expectations, and implement necessary changes to sustain compliance and support commercial readiness.

Experience and qualifications

A bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Engineering, or another related scientific field is required; an advanced degree is preferred.

The role calls for more than 10 years of progressive GMP Quality Assurance experience in biotechnology and/or pharmaceuticals, including support for clinical-stage development programs.

Applicants should have proven experience managing external manufacturing networks that include CMOs, CDMOs, contract laboratories, and critical suppliers.

Strong working knowledge of global GMP and related GxP requirements is essential, including familiarity with FDA, EMA, and ICH guidance.

Experience leading GMP quality activities for small-molecule products across the development lifecycle is required, with particular strength in solid oral dosage form development, manufacturing, and global regulatory compliance.

Experience with investigational products through Phase 2 and Phase 3, as well as commercial readiness, process validation, and lifecycle management, is preferred.

Background supporting regulatory inspections, supplier audits, due diligence, and review of GMP documentation, quality agreements, and regulatory submission content is also expected.

The ideal candidate will be able to apply science-based and risk-based judgment to complex quality and compliance decisions in a fast-moving environment. Experience in a small or emerging biotech company is preferred, along with strong communication skills and the ability to influence both technical teams and executive stakeholders. The role also requires someone who is comfortable operating in a lean environment, building practical quality processes from the ground up, and contributing hands-on where needed.

Why this role stands out

• Opportunity to help shape the strategy of a company working to change the treatment landscape for kidney disease.
• A highly visible position with direct influence on business direction and growth.
• A collaborative, mission-focused culture centered on innovation and urgency.
• The chance to work at the edge of science while helping deliver meaningful business results.

Work location

This position is onsite, with preference for candidates located in the San Francisco Bay Area or the Raleigh-Durham, NC area, though other U.S.-based candidates may be considered.