Senior Director of Quality

Quetzal; Northern (KY); Presencial; USD 180 000 - 280 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

PTO & holidays

Flexible spending accounts

Resumo da oferta

Quetzal Therapeutics seeks a Senior Director of Quality to lead the Quality function, build a phase-appropriate QMS, and support global clinical development and regulatory submissions. This role reports to the CRQO and partners with Regulatory Affairs, Clinical Operations, CMC, and external partners to ensure GxP compliance.

The ideal candidate combines strategic judgment with hands-on execution, managing quality processes in a lean, fast-paced biotech environment and influencing

Qualificações

• Bachelor's degree in Life Sciences or related field.
• 10+ years of progressive Quality Assurance experience in biotech/pharma.
• Experience leading QA programs/teams in clinical development.
• Experience with Phase 1–3 programs and regulatory inspections.
• Knowledge of ICH, GCP, GMP and global GxP regulations.
• Experience auditing CROs, CMOs, labs and GxP providers.

Responsabilidades

• Lead and manage Quality Assurance function.
• Develop and execute the Quality strategy aligned with milestones.
• Advise CRQO and provide executive-quality updates.
• Promote a culture of quality, compliance and continuous improvement.
• Set up and maintain an effective QMS and SOP framework.
• Oversee supplier qualification and vendor quality oversight.
• Lead inspection readiness planning and regulatory interactions.
• Mentor and scale the Quality organization as the company grows.

Conhecimentos

Quality leadership

Regulatory collaboration

Risk-based decision making

Cross-functional influence

Quality metrics & CI

Formação académica

Bachelor's in Life Sciences/Related

Advanced degree (MS/PhD/PharmD/MPH)

Ferramentas

eQMS

GxP Compliance Programs

Descrição da oferta de emprego

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.
• Oncology, hematology, and/or rare disease experience.
• 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.