Senior Director of Quality

🔥 25 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 15%

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Quetzal Therapeutics

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2025

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Quetzal Therapeutics is a clinical-stage company developing oral and formulation-engineered therapies to transform treatment of rare hematologic malignancies and other underserved rare diseases. Its lead candidate, QTX-2101, is an investigational oral formulation of arsenic trioxide in Phase III for acute promyelocytic leukemia (APL), intended to replace IV infusion-based regimens and reduce patient treatment burden. The company also pursues a preclinical program, QTX-2102, aimed at novel antifungal and antiparasitic therapies for rare infectious diseases, and emphasizes proprietary delivery technologies and a stability-first approach to improve tolerability, access, and compliance.

📋 Description

• 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 Chief Regulatory & Quality Officer and provide quality updates and recommendations to executive leadership • Promote a culture of quality, compliance, accountability, and continuous improvement • Set up, maintain, and continuously improve the company's electronic Quality Management System • Oversee controlled documents and SOPs, training, deviations and investigations, CAPAs, change controls, supplier quality, quality risk management, product complaints, and inspection management • Establish scalable quality processes supporting clinical development and future commercialization • 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 • Provide quality oversight of contract manufacturing organizations, testing laboratories, packaging vendors, and other GxP suppliers • Support supplier qualification, quality agreements, performance monitoring, change controls, deviations, investigations, and quality risk evaluations • Partner with CMC and Regulatory Affairs on 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 • Serve as 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 • Develop quality metrics, dashboards, and key performance indicators • Identify compliance trends, systemic risks, and improvement opportunities • Report quality performance, compliance risks, and remediation activities to the CRQO • Build and scale the Quality function • Manage internal quality personnel, external consultants, and contracted audit resources • Mentor team members and establish responsibilities, priorities, and performance expectations

🎯 Requirements

• 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

🏖️ 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

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