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
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.
