Senior Director, GxP Quality

Generate:Biomedicines is seeking a Senior Director of GxP Quality to lead and scale quality strategy and operations. This is a key leadership role focused on clinical quality assurance in late-stage development programs, partnering with clinical, CMC, regulatory, and technical teams to ensure compliant execution of their drug development strategy. The ideal candidate possesses strong technical expertise and a practical approach to quality improvement.

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.
• 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 communication skills with excellent judgment, problem-solving skills, and business acumen.
• Leadership experience in small, high-growth environments with the ability to adapt to change.

Benefits

• Competitive benefits package
• Annual bonus
• Equity compensation