Senior Director, GxP Quality

Summary

Join Generate:Biomedicines as a Senior Director, GxP Quality to lead and scale quality strategy and operations across development-stage programs. This key leadership role involves building and maintaining phase-appropriate quality systems across GCP, GLP, and GMP activities. You will partner with various teams and external partners to ensure compliant execution of Generate’s drug development strategy, focusing on clinical quality assurance in the late stage. Reporting to the SVP, Clinical Drug Development, you will serve as the primary quality leader for clinical development efforts. The ideal candidate possesses deep technical expertise, a pragmatic approach, and the ability to lead in a fast-paced environment. This role requires strong collaboration, influencing skills, and experience in regulatory submissions and inspection readiness.

Requirements

• BS or advanced degree in a scientific or technical field (biology, chemistry, engineering, or equivalent)
• 12+ years of relevant biotech/pharma industry experience, including 8+ years in a GxP quality leadership role
• Strong working knowledge of GCP, GLP, GMP, and global health authority expectations
• Experience working on late stage clinical development is a requirement

Responsibilities

• Lead GxP Quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other applicable regulations
• In collaboration with the Director of Quality, Develop and maintain a phase-appropriate Quality Management System (QMS), including SOPs, training, document control, and vendor oversight
• Oversee and support GCP, GLP, and GMP quality activities, including audits, deviation management, CAPAs, and quality agreements with CROs, CDMOs, and other partners
• Serve as a key Quality point of contact for internal teams and external vendors, providing guidance on compliance expectations and issue resolution
• Collaborate cross-functionally to ensure quality considerations are embedded early in clinical and CMC planning
• Serve as a resource and partner cross-functionally, and particularly for those team members involved in clinical development
• Where necessary, lead or support regulatory inspections, readiness efforts, and submission preparation (e.g., IND, BLA)
• Develop quality metrics and indicators that enable proactive oversight and continuous improvement
• Champion a culture of quality and compliance across the organization through training, communication, and role-modeling
• Manage a small quality team and external consultants or contractors as needed to meet business demands

Preferred Qualifications

• Experience building or scaling a quality function in a growing or early-stage company is highly desirable
• Demonstrated ability to influence cross-functional teams and external partners
• Prior experience with regulatory submissions (e.g., IND, BLA, MAA) and inspection readiness preferred
• Strong communicator with excellent judgment, problem-solving skills, and business acumen
• Leadership experience in small, high-growth environments with the ability to adapt to change and work hands-on