Director, Quality Assurance — Biotech (First QA Hire)

TriNet Group; Berkeley (CA); On-site; USD 185,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity grants

Medical, dental, vision

Job summary

Azalea Therapeutics is seeking a Director/Senior Director of Quality Assurance to build and lead the QA function as the company advances its pipeline toward first‑in‑human studies. This hands‑on leadership role requires establishing a robust QMS, support for GMP readiness, and tight collaboration with CMC, Regulatory, and Clinical teams.

The role is onsite in Berkeley with 2–3 days per week in the office, offering a competitive compensation package including salary, annual bonus, and equity.

Qualifications

• 10+ years of progressive Quality Assurance leadership experience in biotech
• Experience partnering with CDMOs and external labs in GMP
• Proven track record establishing and scaling QA systems in biotech environments

Responsibilities

• Build and lead Azalea’s QA function including strategy, operating model, and resourcing for an early-stage company.
• Establish phase-appropriate QMS, SOPs, document control, deviation and CAPA management, change control, risk management.
• Partner with CMC, Process Development, Regulatory Affairs, Clinical, and CDMO partners to embed quality in program planning.

Skills

QA leadership

GxP compliance

CDMO oversight

Regulatory submissions

Cross-functional leadership

Quality systems

Education

Bachelor's degree in life sciences or related

Job description

Azalea Therapeutics is seeking a Director/Senior Director of Quality Assurance to build and lead the QA function as the company advances its pipeline toward first‑in‑human studies. This hands‑on leadership role requires establishing a robust QMS, support for GMP readiness, and tight collaboration with CMC, Regulatory, and Clinical teams.

The role is onsite in Berkeley with 2–3 days per week in the office, offering a competitive compensation package including salary, annual bonus, and equity.