Senior Director, Quality Assurance & Compliance

Quetzaltx; United States; Remote; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health benefits package

Paid time off

Job summary

Quetzal Therapeutics seeks a highly experienced Senior Director of Quality to lead the Quality function and establish a scalable QMS for global clinical development, regulatory submissions, and future commercialization. Reporting to the CRQO, you will develop and continuously improve GxP quality systems and QA programs across internal teams and external partners.

The role demands strategic judgment, operational execution, and risk-based decision-making in a fast-paced biotech setting, with

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or related field.
• 10+ years of progressive QA experience in biotech/pharma.
• Experience leading quality programs in clinical-stage environments.
• Experience with GCP/GMP, regulatory inspections, and audits.

Responsibilities

• Lead Quality Assurance function and strategic quality initiatives.
• Develop and maintain phase-appropriate QMS and SOPs.
• Provide oversight of global clinical programs and inspections.
• Partner with CMC, Regulatory Affairs, and CROs/CMOs.

Skills

Quality leadership

GxP compliance

Regulatory inspections

CRO/CMO oversight

Risk management

Education

Bachelor's in Life Sciences/ related field

Advanced degree preferred

Tools

eQMS

Quality systems

Job description

Quetzal Therapeutics seeks a highly experienced Senior Director of Quality to lead the Quality function and establish a scalable QMS for global clinical development, regulatory submissions, and future commercialization. Reporting to the CRQO, you will develop and continuously improve GxP quality systems and QA programs across internal teams and external partners.

The role demands strategic judgment, operational execution, and risk-based decision-making in a fast-paced biotech setting, with