Director of Quality Assurance, Biotech

New Horizon Medical Solutions LLC.; Berkeley (CA); On-site; USD 185,000 - 260,000; Full time

Benefits offered by this job

Bonus/Equity eligible

Job summary

Azalea Therapeutics in Berkeley seeks a Director/Senior Director, Quality Assurance to establish QA for external manufacturing and regulatory readiness. You will lead a function ensuring patient safety, data integrity, and GMP compliance in an early-stage company.

This hands-on leadership role partners with CMC, Regulatory Affairs, Clinical teams, and CDMOs, aiming to advance pipeline programs toward first-in-human studies while maintaining high standards and clear accountability.

Qualifications

• 10+ years of progressive Quality Assurance leadership experience in biotechnology with manufacturing and external partner oversight.
• Demonstrated experience partnering with CDMOs and external testing laboratories in a GMP environment.
• Strong track record establishing and scaling quality systems, SOPs, vendor oversight, and batch release processes in biotech.

Responsibilities

• Build and lead the QA function aligned to early-stage biotech goals.
• Establish a phase-appropriate QMS, SOPs, training, deviation and CAPA, change control, vendor qualification, audit planning, and quality metrics.
• Partner with CMC, Process Development, Analytical Development, Regulatory Affairs, Clinical, and external partners to embed quality into program planning and execution.
• Lead QA oversight of external consultants, CDMOs, testing labs, and GxP vendors, including quality agreements and audits.
• Establish batch release and disposition processes for development, GMP, and clinical materials.
• Provide QA leadership for EDV and AAV manufacturing/analytics with phase-appropriate controls.
• Define and maintain labeling, packaging, and clinical supply documentation requirements (US and international).
• Support regulatory strategy and submissions by contributing quality content and ensuring commitments are tracked.

Skills

Quality leadership

GMP compliance

External manufacturing oversight

Regulatory submissions support

Cross-functional leadership

Education

Bachelor’s degree in life sciences

Job description

Azalea Therapeutics in Berkeley seeks a Director/Senior Director, Quality Assurance to establish QA for external manufacturing and regulatory readiness. You will lead a function ensuring patient safety, data integrity, and GMP compliance in an early-stage company.

This hands-on leadership role partners with CMC, Regulatory Affairs, Clinical teams, and CDMOs, aiming to advance pipeline programs toward first-in-human studies while maintaining high standards and clear accountability.