[Hiring] Senior Director of Quality @Quetzal Therapeutics

Role Description

Quetzal Therapeutics seeks a highly experienced and hands-on Senior Director of Quality to lead the company's Quality function and establish a scalable, phase-appropriate Quality Management System (QMS) supporting global clinical development, regulatory submissions, and future commercialization activities.

Reporting directly to the Chief Regulatory & Quality Officer, the Senior Director of Quality will be responsible for the development, implementation, and continuous improvement of Quetzal's GxP quality systems, quality assurance programs, inspection readiness capabilities, and compliance infrastructure. This individual will work closely with:

• Regulatory Affairs
• Clinical Operations
• CMC
• Medical Affairs
• External partners

The ideal candidate will combine strategic judgment with strong operational execution and will be comfortable building and managing quality processes in a lean, fast-paced biotechnology organization. They will demonstrate:

• Sound business judgment
• A risk-based approach to decision-making
• The ability to influence cross-functional teams
• Management of competing priorities
• Building collaborative relationships across internal and external stakeholders
• Maintaining the highest standards of quality and compliance

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related discipline.
• 10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or life sciences industry.
• Demonstrated experience leading quality programs and/or teams within a clinical-stage biotechnology or pharmaceutical environment.
• Experience supporting Phase 1 through Phase 3 clinical development programs.
• Demonstrated experience implementing, maintaining, and continuously improving phase-appropriate Quality Management Systems (QMS).
• Direct experience with GCP and GMP compliance programs, regulatory inspections, audits, and quality systems.
• Strong experience qualifying, auditing, and overseeing CROs, CMOs, laboratories, and other GxP service providers.
• Experience interacting with health authorities and supporting FDA, EMA, or comparable regulatory inspections.
• Knowledge of applicable global GxP regulations, ICH guidelines, and quality risk management principles.

Requirements

• Advanced degree (MS, PharmD, PhD, MPH, or equivalent).
• Experience supporting NDA, BLA, MAA, or other marketing application preparation and submission activities.
• Experience implementing, managing, or optimizing an electronic Quality Management System (eQMS).
• Experience supporting organizations transitioning from late-stage clinical development to commercial readiness.
• Experience building or scaling Quality systems within an emerging or growth-stage biotechnology company.
• Oncology, hematology, and/or rare disease experience.
• Experience supporting international regulatory inspections and global development programs.

Benefits

• Comprehensive medical, dental, and vision coverage
• Health and flexible spending account options
• Paid time off, sick leave, and company holidays
• Additional voluntary benefit options

Company Description

Quetzal Therapeutics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law.