Direct experience with Good Clinical Practice and Good Manufacturing Practice compliance programs, regulatory inspections, audits, and quality systems.
Strong experience qualifying, auditing, and overseeing contract research organizations, contract manufacturing organizations, 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.
Responsibilities
Lead and manage the company's Quality Assurance function.
Develop and execute the company's Quality strategy in alignment with corporate objectives and development milestones.
Serve as the primary quality advisor to the Chief Regulatory & Quality Officer and provide quality updates and recommendations to executive leadership.
Promote a culture of quality, compliance, accountability, and continuous improvement across the organization.
Set up, maintain, and continuously improve the company's overall and electronic Quality Management System.
Lead and oversee controlled documents and standard operating procedures, training, deviations and investigations, corrective and preventive actions, change controls, supplier quality, quality risk management, product complaints, and inspection management.
Establish practical, scalable quality processes that support clinical development and future commercialization.
Monitor Quality Management System effectiveness and drive timely remediation of identified gaps.
Provide quality oversight of global clinical development programs.
Develop and execute risk-based audit programs covering clinical sites, contract research organizations, central laboratories, technology vendors, and clinical systems and processes.
Support protocol compliance, data integrity, patient safety, and risk-based quality management activities.
Maintain inspection readiness throughout clinical trial execution.
Provide quality oversight of contract manufacturing organizations, testing laboratories, packaging vendors, and other GxP suppliers.
Support supplier qualification, quality agreements, ongoing performance monitoring, change control assessments, deviations, investigations, and quality risk evaluations.
Partner with CMC and Regulatory Affairs to support late-stage development, registration, and supply readiness.
Lead company-wide inspection readiness planning and execution.
Develop and conduct mock inspections, readiness assessments, and inspection training.
Support regulatory submissions and health authority interactions by ensuring applicable quality and compliance expectations are addressed.
Serve as the operational Quality lead during regulatory authority inspections and partner audits.
Establish and maintain a risk-based supplier qualification and oversight program.
Plan, conduct, and oversee vendor audits and assessments.
Monitor supplier quality performance and drive corrective and preventive actions when needed.
Develop quality metrics, dashboards, and key performance indicators.
Identify compliance trends, systemic risks, and opportunities for proactive improvement.
Provide regular updates on quality performance, compliance risks, and remediation activities to the Chief Regulatory & Quality Officer.
Build and scale the Quality function as the company grows.
Manage internal quality personnel, external consultants, and contracted audit resources.
Mentor team members and establish clear responsibilities, priorities, and performance expectations.
Desired Qualifications
An 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.
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.
Experience supporting international regulatory inspections and global development programs.
About Quetzal Therapeutics LLC
Quetzal Therapeutics is a biopharmaceutical company focused on the development of treatment for rare diseases including hematologic malignancies. The company’s lead product is QTX-2101, a novel paradigm for treating patients with Acute Promyelocytic Leukemia (APL) for which the company initiated a Phase III clinical trial in December 2025. Quetzal is also developing a pre-clinical asset QTX-2102, an advanced, next-generation antifungal and antiparasitic therapy designed to enhance efficacy while minimizing toxicity. Our mission is to push the boundaries of treatment possibilities, delivering hope and life-changing solutions to those who need them most.
About the role
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, and external partners to ensure adherence to applicable global regulatory and quality requirements and industry standards.
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, and the ability to influence cross-functional teams, manage competing priorities, and build collaborative relationships across internal and external stakeholders while maintaining the highest standards of quality and compliance.
Why Join Us
This is an opportunity to play a highly visible, hands-on role in shaping Quetzal’s Quality function during a critical stage of growth and clinical development. You will have the opportunity to build and strengthen scalable quality systems, influence cross-functional strategy, and help ensure the organization is prepared for key regulatory and development milestones.
What You'll Do
Quality Leadership and Strategy
Lead and manage Quetzal's Quality Assurance function.
Develop and execute the company's Quality strategy in alignment with corporate objectives and development milestones.
Serve as the primary quality advisor to the CRQO and provide quality updates and recommendations to executive leadership.
Promote a culture of quality, compliance, accountability, and continuous improvement across the organization.
Quality Management System (QMS)
Set up the overall QMS for the Company and maintain and continuously improve the company's electronic QMS.
Lead, manage and oversee controlled documents and SOPs, training, deviations and investigations, CAPAs, change controls, supplier quality, quality risk management, product complaints, and inspection management.
Establish practical, scalable quality processes that support clinical development and future commercialization.
Monitor the effectiveness of the QMS and drive timely remediation of identified gaps.
Clinical Quality Assurance
Provide quality oversight of global clinical development programs.
Develop and execute risk-based audit programs covering clinical sites, CROs, central laboratories, technology vendors, and clinical systems and processes.
Support protocol compliance, data integrity, patient safety, and risk-based quality management activities.
Maintain inspection readiness throughout clinical trial execution.
GMP and CMC Quality Oversight
Provide quality oversight of contract manufacturing organizations, testing laboratories, packaging vendors, and other GxP suppliers.
Support supplier qualification, quality agreements, ongoing performance monitoring, change control assessments, deviations, investigations, and quality risk evaluations.
Partner with CMC and Regulatory Affairs to support late-stage development, registration, and supply readiness.
Inspection Readiness and Regulatory Support
Lead company-wide inspection readiness planning and execution.
Develop and conduct mock inspections, readiness assessments, and inspection training.
Support regulatory submissions and health authority interactions by ensuring that applicable quality and compliance expectations are addressed.
Serve as the operational Quality lead during regulatory authority inspections and partner audits.
Supplier and Vendor Quality Management
Establish and maintain a risk-based supplier qualification and oversight program.
Plan, conduct, and oversee vendor audits and assessments.
Monitor supplier quality performance and drive corrective and preventive actions when needed.
Quality Metrics and Continuous Improvement
Develop meaningful quality metrics, dashboards, and key performance indicators.
Identify compliance trends, systemic risks, and opportunities for proactive improvement.
Provide regular updates on quality performance, compliance risks, and remediation activities to the CRQO.
Team and Resource Management
Build and scale the Quality function as Quetzal grows.
Manage internal quality personnel, external consultants, and contracted audit resources.
Mentor team members and establish clear responsibilities, priorities, and performance expectations.
What You'll Bring
Required 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.
Preferred Qualifications
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.
Experience supporting international regulatory inspections and global development programs.
Benefits & What We Offer
Quetzal Therapeutics offers eligible employees a competitive benefits package designed to support their health, wellbeing, and work-life balance. Our benefits include:
Comprehensive medical, dental, and vision coverage
Health and flexible spending account options
Paid time off, sick leave, and company holidays
Additional voluntary benefit options
Benefits and eligibility may vary based on employment status, location, and applicable plan terms and company policies.
Equal Opportunity Employer
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.