Director, Quality Systems

Accountabilities: Quality Management System leadership: Develop, implement, maintain, and continuously improve an integrated QMS covering GxP activities, ensuring alignment and consistency across GMP and GCP quality functions. Quality governance and core processes: Own and optimize key quality processes, including deviations, corrective and preventive actions (CAPA), change control, document control, training, risk management, and computerized system validation (CSV) and computer software assurance (CSA). Computerized systems and data integrity: Provide quality oversight and approval of computerized system validation deliverables and related quality events, ensuring appropriate lifecycle management, risk-based validation, and data integrity controls. Quality performance and continuous improvement: Establish meaningful quality metrics, prepare quarterly dashboards, lead Quality System Management Reviews, and track corrective actions to strengthen accountability and performance. Post-market quality oversight: Oversee complaint intake, documentation, investigations, coordination with outsourced vendors, and recall procedures, serving as a key liaison for associated quality activities. Regulatory inspections and audit readiness: Lead inspection preparation, support regulatory inspections and audits, including Pre-Approval Inspections (PAIs), and establish and maintain an effective audit schedule and program. Cross-functional collaboration: Partner with internal stakeholders, GMP and GCP quality leaders, and external service providers to integrate quality requirements into business processes while balancing regulatory obligations with operational needs. Scalable quality infrastructure: Build and refine efficient, risk-based processes that can evolve with organizational growth and support commercialization readiness. Team leadership and accountability: Lead quality professionals and foster a culture of quality ownership, continuous improvement, regulatory compliance, and operational excellence. Requirements Bachelor's degree in a scientific discipline or related field; an advanced degree is an advantage. At least 8 years of experience in GxP Quality within the biotechnology or pharmaceutical industry, including experience across both GMP and GCP environments. Demonstrated experience leading quality professionals and building, implementing, or managing a comprehensive Quality Management System. Strong knowledge of enterprise QMS processes, including deviations, CAPA, change control, document control, training, and risk management. Expertise in computerized system validation or computer software assurance, including lifecycle management, risk-based validation approaches, and data integrity practices. Direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs). Strong communication, leadership, and stakeholder management skills, with the ability to collaborate effectively across functions and with external partners. Experience working in a growing or evolving organization, with the ability to establish structure while remaining adaptable and responsive to changing business needs. Sound judgment, strong ownership, and a practical, business-oriented approach to problem-solving and continuous improvement. A quality-related professional certification is preferred. Experience scaling quality systems to support organizational growth, commercialization, or launch readiness is an advantage. Benefits Base salary: $220,000–$235,000 USD annually, depending on experience, skills, qualifications, and internal equity. Annual incentive: Eligible for an annual target bonus. Equity compensation: Eligible for equity compensation, subject to the compensation committee's determination. Healthcare: Medical, dental, and vision insurance. Retirement and savings: 401(k) retirement plan and participation in an Employee Stock Purchase Plan. Insurance protection: Company-paid life insurance and short- and long-term disability coverage. Time off: Paid time off and paid company holidays. Work arrangement: Fully remote within the continental United States. Travel: Up to 10% travel for conferences and company meetings. Professional impact: Opportunity to shape enterprise quality systems, strengthen inspection readiness, and support the commercialization of an innovative treatment.