Director of Quality Assurance

Company Overview: AirNexis Therapeutics is a clinical stage biotechnology company headquartered in Palo Alto, California. Guided by a seasoned leadership team, a strong investor syndicate and a clear therapeutic focus, AirNexis is working to deliver a next generation maintenance therapy for COPD that may provide improved efficacy and an enhanced patient experience compared to currently available treatments. Through its licensed asset, late-stage development focus and global strategy, AirNexis aims to establish a meaningful presence in the respiratory therapeutics landscape. The company’s lead program is AN01, a dual PDE3 and PDE4 inhibitor that aims to deliver both bronchodilation and anti-inflammatory activity in a single therapy. Position Summary As we advance our clinical programs, we are seeking an experienced and hands-on Director of Quality Assurance to build, strengthen, and lead quality operations across our organization. This is a highly visible leadership role that combines strategic quality leadership with day-to-day operational execution. The ideal candidate is comfortable rolling up their sleeves in a fast-paced startup environment while helping establish scalable quality systems that support clinical development and future commercialization. This position will provide leadership and oversight for the company's GxP Quality Management System and serve as the primary QA representative across Manufacturing, Quality Control, Regulatory, Technical Operations, and Supply Chain. This individual will ensure compliance with applicable FDA, ICH, EU, and global GxP regulations while supporting the company's clinical manufacturing and supply activities. Our successful candidate will thrive in a collaborative startup environment where flexibility, initiative, and sound judgment are essential. Responsibilities: Quality Systems & Leadership Lead the development, implementation, and continuous improvement of the Quality Management System (QMS). Establish and maintain quality policies, procedures, and quality metrics. Provide strategic quality leadership to support company growth, clinical development, and future commercial readiness. Serve as the Quality representative on cross-functional project teams. Foster a culture of quality throughout the organization. Manufacturing & Batch Disposition Perform QA review and approval of GMP manufacturing batch records. Review executed production documentation for completeness, accuracy, and compliance. Lead batch disposition activities for clinical products. Perform QA release of batches for ex-U.S. clinical studies. Serve as Quality approver for U.S. lot release strategy and disposition activities. Support investigations, deviations, CAPAs, change controls, and risk assessments related to manufacturing operations. Quality Control Oversight Provide QA oversight of Quality Control laboratory operations. Review and approve analytical methods, method transfers, validation documentation, specifications, protocols, and reports. Ensure laboratory activities comply with applicable GMP and data integrity requirements. Partner with QC to resolve investigations, out-of-specification (OOS), out-of-trend (OOT), and analytical deviations. Supply Chain Quality Provide end-to-end QA oversight across the GMP supply chain, including raw materials, contract manufacturers, testing laboratories, packaging, labeling, storage, and distribution. Ensure appropriate quality oversight for external manufacturing and testing partners. Review and approve quality agreements with contract organizations. Support qualification and ongoing management of suppliers and service providers. Supplier & Vendor Quality Plan, conduct, and report supplier and contract organization audits. Lead qualification and periodic requalification of GMP suppliers. Track audit observations and ensure timely implementation of corrective and preventive actions. Inspection & Compliance Maintain inspection readiness for FDA and international regulatory inspections. Support regulatory submissions by providing QA review of relevant documentation. Monitor evolving regulatory expectations and implement improvements to maintain compliance. Qualifications Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline. 10+ years of progressive Quality Assurance experience within the biotechnology or pharmaceutical industry. Strong background supporting GMP manufacturing operations. Demonstrated experience reviewing and approving manufacturing batch records and batch disposition decisions. Experience providing QA oversight for Quality Control laboratories and analytical methods. Working knowledge of FDA, EU GMP, ICH, and global GxP regulations. Experience supporting CDMOs, contract laboratories, and external manufacturing networks. Experience conducting supplier and GMP audits. Strong understanding of deviations, investigations, CAPAs, change control, risk management, and data integrity principles. Excellent communication, organizational, and cross-functional leadership skills. Ability to balance strategic initiatives with hands‑on operational responsibilities in a startup environment. Candidate located in, or willing to relocate to, the San Francisco Bay Area. Hybrid on‑site presence is strongly preferred. *The level of this role will be based on candidate’s skills and qualifications.* #J-18808-Ljbffr