Senior Director of Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct and oversee the Quality Assurance function at Quetzal.

• Formulate and implement the company's Quality strategy to align with corporate goals and developmental milestones.

• Act as the chief quality advisor to the Chief Regulatory & Quality Officer, providing quality updates and strategic recommendations to the executive team.

• Foster a culture of quality, compliance, accountability, and ongoing improvement.

• Establish, sustain, and enhance the company's electronic Quality Management System.

• Manage controlled documents and SOPs, training, deviations and investigations, CAPAs, change controls, supplier quality, quality risk management, product complaints, and inspection management.

• Create scalable quality processes to support clinical development and future commercialization efforts.

• Offer quality oversight for global clinical development programs.

• Design and implement risk-based audit programs for clinical sites, CROs, central laboratories, technology vendors, and clinical systems and processes.

• Assist in protocol compliance, data integrity, patient safety, and risk-based quality management initiatives.

• Ensure inspection readiness throughout the execution of clinical trials.

• Provide quality oversight for contract manufacturing organizations, testing laboratories, packaging vendors, and other GxP suppliers.

• Aid in supplier qualification, quality agreements, performance monitoring, change controls, deviations, investigations, and quality risk evaluations.

• Collaborate with CMC and Regulatory Affairs on late-stage development, registration, and supply readiness.

• Spearhead company-wide planning and execution for inspection readiness.

• Develop and conduct mock inspections, readiness evaluations, and inspection training programs.

• Support regulatory submissions and interactions with health authorities.

• Serve as the operational Quality lead during inspections by regulatory authorities and partner audits.

• Establish and maintain a risk-based supplier qualification and oversight program.

• Plan, execute, and supervise 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 opportunities for improvement.

• Report on quality performance, compliance risks, and remediation efforts to the CRQO.

• Build and scale the Quality function.

• Oversee internal quality personnel, external consultants, and contracted audit resources.

• Mentor team members and establish responsibilities, priorities, and performance expectations.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related field.

• Over 10 years of progressive Quality Assurance experience in the biotechnology, pharmaceutical, or life sciences sectors.

• Proven experience leading quality programs and/or teams within a clinical-stage biotechnology or pharmaceutical setting.

• Experience supporting clinical development programs from Phase 1 through Phase 3.

• Demonstrated ability to implement, maintain, and continuously enhance phase-appropriate Quality Management Systems (QMS).

• Direct experience with GCP and GMP compliance programs, regulatory inspections, audits, and quality systems.

• Strong background in qualifying, auditing, and managing CROs, CMOs, laboratories, and other GxP service providers.

• Experience engaging with health authorities and supporting FDA, EMA, or similar regulatory inspections.

• Familiarity with applicable global GxP regulations, ICH guidelines, and principles of quality risk management.

🏝️ Benefits

• Comprehensive medical, dental, and vision coverage.

• Options for health and flexible spending accounts.

• Paid time off, sick leave, and company-recognized holidays.

• Additional voluntary benefit options available.