[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.
Responsibilities
- Lead 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 commercialization
- 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 approach
- 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 applicable
- Partner with CMC, Technical Operations, Regulatory Affairs, and Supply Chain to support technology transfer, validation, process monitoring, comparability, lifecycle management, and uninterrupted clinical supply
- Lead inspection readiness and support regulatory inspections, partner audits, due diligence activities, and preparation of quality and CMC content for regulatory submissions and responses
- Assess and escalate quality and compliance risks to leadership, providing clear, risk-based recommendations while fostering a culture of quality, compliance, and continuous improvement
- Stay current with global GMP regulations and industry expectations, and proactively implement changes needed to maintain compliance and support commercial readiness
Skills
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required; advanced degree preferred
- 10+ years of progressive GMP Quality Assurance experience in biotechnology and/or pharmaceuticals, including support for clinical-stage development programs
- Demonstrated experience overseeing external manufacturing networks, including CMOs, CDMOs, contract laboratories, and critical suppliers
- Strong knowledge of global GMP and applicable GxP requirements, including FDA, EMA, and ICH guidance
- 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 compliance
- Experience leading or supporting regulatory inspections, supplier audits, due diligence, and review of GMP documentation, quality agreements, and regulatory submission content
- Ability to apply science- and risk-based decision making to complex quality and compliance issues in a fast-paced environment
- Ability to work effectively in a lean environment; hands-on, resourceful, and comfortable providing Quality input and building processes without well-established infrastructure
- Advanced degree preferred
- Experience supporting investigational products from Phase 2 through Phase 3, with commercial readiness, process validation, and lifecycle management experience preferred
- Experience in small or emerging biotechnology companies preferred, along with strong communication skills and the ability to influence technical and executive stakeholders
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