Senior Director of Quality

Quetzal Therapeutics

36d

About The Position

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.

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.

Nice To Haves

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.

Responsibilities

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.
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.
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, 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 that 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 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.
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.