Director of Quality Assurance - Biotech (Hybrid, Equity Eligible)

Azalea Therapeutics; Berkeley (CA); On-site; USD 185,000 - 260,000; Full time

Benefits offered by this job

Annual performance bonus

Equity grants

Medical, dental, vision coverage

Job summary

Azalea Therapeutics seeks a Director/Senior Director of Quality Assurance to build and lead the QA function in an early-stage biotech setting. You will drive a phase-appropriate QMS, partner across CMC, Regulatory Affairs, and Clinical teams, and oversee external vendors to ensure patient safety and data integrity.

The role is onsite in Berkeley, CA, with 2-3 days per week in the office and a focus on regulatory readiness and first‑in‑human readiness for AZA-2509 and pipeline programs.

Qualifications

• Minimum Qualifications include 10+ years in QA leadership within biotech or gene therapy.
• Experience partnering with CDMOs and external laboratories in GMP.
• Proven ability to establish and scale QA systems, SOPs, vendor oversight, and batch release processes.

Responsibilities

• Build and lead Azalea’s QA function and quality strategy.
• Implement phase-appropriate QMS, document control, training, CAPA, and audits.
• Partner with CMC, Regulatory Affairs, Clinical, and external partners to ensure quality in planning and execution.
• Lead QA oversight of CDMOs, testing labs, and other vendors, including audits and performance management.
• Establish batch release and disposition processes for development and GMP materials.

Skills

Quality Assurance leadership

GxP oversight

CDMO collaboration

Vendor qualification

Batch release & disposition

Risk management

Cross-functional leadership

Quality systems development

Education

Bachelor’s degree in life sciences, engineering, quality

Job description

Azalea Therapeutics seeks a Director/Senior Director of Quality Assurance to build and lead the QA function in an early-stage biotech setting. You will drive a phase-appropriate QMS, partner across CMC, Regulatory Affairs, and Clinical teams, and oversee external vendors to ensure patient safety and data integrity.

The role is onsite in Berkeley, CA, with 2-3 days per week in the office and a focus on regulatory readiness and first‑in‑human readiness for AZA-2509 and pipeline programs.