Biotech Quality Leader: Strategy, QMS & Inspections

Quetzal Therapeutics; United States; À distance; USD 180 000 - 280 000; Plein temps

Avantages offerts par ce poste

Comprehensive medical, dental, and виз

Résumé du poste

Quetzal Therapeutics seeks a seasoned Senior Director of Quality to lead the Quality function and establish a scalable QMS for global clinical development and regulatory submissions. You will report to the Chief Regulatory & Quality Officer and work closely with Regulatory Affairs, Clinical Operations, CMC, and medical affairs.

The role combines strategic oversight with hands-on execution in a lean biotech setting, emphasizing risk-based decision-making, inspection readiness, and

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 10+ years of progressive QA in biotech/pharma.
• Leadership of quality programs within clinical-stage environments.

Responsabilités

• Lead and shape the company’s Quality function and strategy.
• Develop and maintain phase-appropriate QMS and inspection readiness.
• Oversee QA programs for clinical development, CMC, and GMP suppliers.
• Partner with Regulatory, Clinical Operations, and external partners.
• Drive continuous improvement and risk-based decision making.

Connaissances

Quality leadership

GxP compliance

Regulatory strategy

Cross-functional leadership

Audit programs

Quality systems

Vendor management

Formation

Bachelor's in Life Sciences

Advanced degree preferred

Outils

eQMS

GxP systems

Regulatory submissions software

Description du poste

Quetzal Therapeutics seeks a seasoned Senior Director of Quality to lead the Quality function and establish a scalable QMS for global clinical development and regulatory submissions. You will report to the Chief Regulatory & Quality Officer and work closely with Regulatory Affairs, Clinical Operations, CMC, and medical affairs.

The role combines strategic oversight with hands-on execution in a lean biotech setting, emphasizing risk-based decision-making, inspection readiness, and