Director/Senior Director, Quality Assurance

Job Title: Director/Senior Director, Quality Assurance Department: Quality Reports to: CEO Location: Onsite, 2-3 days/week – Berkeley, CA Employment Type: Full-Time FLSA Status: Exempt Bonus/Equity: Eligible About Azalea Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo .Azalea is pioneering a new way to turn a person’s own T cells into a powerful cancer therapy — directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers. Why This Matters We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body. Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer. This technology has the potential to treat a wide range of cancers with a streamlined, scalable process. Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients. Role Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable, adaptable, rigorous, humble, and direct. Across roles and functions, we look for team members who demonstrate the following: Outcome Ownership - We own results, close loops, and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions, deliverables, and handoffs do not fall through the cracks. Comfort with Ambiguity - We operate in an early-stage environment where information may be incomplete and priorities may evolve. We clarify quickly, make thoughtful decisions with the information available, and adapt without unnecessary drama. High Standards, Low Ego - We care deeply about the quality of the work and the impact it can have for patients. We raise the bar while staying humble, direct, and open to feedback. Collaboration and Candor - We share context early, communicate clearly, partner across functions, and operate with transparency. We believe strong collaboration requires both trust and direct communication. The Opportunity The Director/Senior Director, Quality Assurance will be Azalea’s first dedicated Quality Assurance hire and will build the QA function required to support external manufacturing, GMP readiness, regulatory interactions, and future clinical supply. This is a hands‑on leadership role for a Quality Assurance leader who can establish phase‑appropriate and right‑sized systems in an early‑stage company while maintaining rigorous standards for patient safety, data integrity, and regulatory compliance. The role will partner closely with CMC, Process Development, Analytical Development, Regulatory Affairs, Clinical, and CDMO partners and consultants to advance AZA‑2509 and pipeline programs toward first‑in‑human clinical development. Key Responsibilities Build and lead Azalea’s Quality Assurance function, including the quality strategy, operating model, roadmap, and resourcing plan appropriate for an early-stage biotechnology company advancing toward first‑in‑human studies. Establish, implement, and continuously improve a phase-appropriate Quality Management System, including SOPs, document control, training, deviation and CAPA management, change control, risk management, vendor qualification, batch record review, product disposition, audits, complaints, and quality metrics. Serve as the QA business partner to CMC, Process Development, Analytical Development, External Manufacturing, Regulatory Affairs, Clinical, and Program Team leaders to ensure quality considerations are embedded into program planning and execution. Lead QA oversight of external consultants, CDMOs, testing laboratories, and other GxP vendors, including quality agreements, vendor qualification, audit planning, issue escalation, and ongoing performance management. Establish and execute batch release and disposition processes for development, engineering, GMP, and future clinical materials, including review of batch records, deviations, investigations, analytical data packages, certificates of analysis, and supporting documentation. Provide QA leadership for EDV and AAV manufacturing and analytics, including phase‑appropriate controls for process development, analytical method development, pilot runs, engineering runs, and GMP manufacturing readiness. Define and maintain quality requirements for labeling, packaging, and clinical supply documentation, including awareness of requirements that may apply inside and outside the United States. Support regulatory strategy and submissions by contributing quality content, reviewing CMC documentation, preparing for health authority interactions, and ensuring commitments are tracked and closed. Prepare the organization and work with external partners for audits and inspections by establishing inspection readiness practices, maintaining traceable documentation, and leading response planning for quality observations. Develop practical quality risk management approaches that help Azalea make sound decisions in an early‑stage environment while protecting patient safety, product quality, and data integrity. Translate quality strategy into clear priorities, accountabilities, and decision points; close loops on issues that cross internal functions and external partners. As the function grows, recruit, develop, and lead QA team members and consultants, setting expectations for high standards, direct communication, and accountable follow-through. Qualifications Minimum Qualifications 10 + years of progressive Quality Assurance leadership experience in biotechnology, biologics, cell therapy, gene therapy, or another complex modality with manufacturing and external partner oversight. Demonstrated experience partnering with CDMOs and external testing laboratories in a GMP environment. Proven track record establishing and scaling quality systems, SOPs, quality agreements, vendor oversight practices, and batch release processes in a biotechnology setting. Hands‑on experience with product batch record review, deviation assessment, CAPA, change control, product disposition, and release documentation. Strong working knowledge of applicable GxP expectations and relevant U.S. and international Quality requirements for investigational products, clinical supply, labeling, documentation, and external manufacturing oversight. Experience supporting regulatory submissions, health authority interactions, audits, and inspection readiness activities. Ability to operate as both a strategic function builder and a hands‑on executor in an early‑stage company environment. Strong cross‑functional leadership skills, including the ability to influence senior stakeholders, drive alignment, and make clear recommendations when information is incomplete. Bachelor’s degree in life sciences, engineering, quality, or a related discipline, or an equivalent combination of education and relevant experience. Preferred Qualifications Experience in cell therapy, gene therapy, in vivo genome editing, AAV, viral vectors, biologics, or other advanced therapy medicinal products. Experience as the first or early Quality hire in a start‑up or small biotechnology company. Experience building a QA organization from the ground up, including use of consultants and external specialists before full internal teams are in place. Experience supporting first‑in‑human readiness, pre‑IND preparation, or early clinical development programs. What Success Looks Like (first 3–6 months) Assess Azalea’s current quality systems, external partner oversight, and overall GMP readiness. Translate findings into a practical QA roadmap aligned with first‑in‑human priorities. Establish or advance the highest‑priority elements of a phase‑appropriate QMS, including document control, training, deviation/CAPA, change control, vendor qualification, audit planning, and quality metrics. Build effective QA partnerships with CMC, Process Development, Analytical Development, Regulatory Affairs, Clinical, and external CDMO/testing partners to clarify expectations, close gaps, and strengthen execution. Establish foundational batch review, product disposition, quality agreement, and vendor oversight processes for development, engineering, GMP, and future clinical materials. Working Conditions / Physical Requirements Onsite 2-3 days per week in our Berkeley office Travel up to 25% Compensation And Benefits The expected salary range for this role based on the primary location for this position in California is $ 185 ,000 - $ 260 ,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law. Salary will be commensurate with experience, qualifications, training and market. This role is eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off. Azalea’s Commitments Equal Employment Opportunity (EEO): Azalea is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable law. Reasonable Accommodation: We will provide reasonable accommodation to qualified individuals with disabilities and to individuals with #J-18808-Ljbffr Azalea Therapeutics