Senior Director, GxP Quality

Senior Director, GxP Quality

Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate : Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role

We are seeking a Senior Director, GxP Quality to lead and scale quality strategy and operations across our development-stage programs. This is a key leadership role responsible for building and maintaining phase-appropriate quality systems across GCP, GLP, and GMP activities. The Senior Director will partner cross-functionally with Clinical Development, CMC, Regulatory, Technical Operations, and external partners to ensure compliant execution of Generate's drug development strategy, with their primary focus on clinical quality assurance in the late stage.

This role will report to the SVP, Clinical Drug Development, and serve as the primary quality leader for clinical development efforts. The ideal candidate brings deep technical expertise, a pragmatic mindset and hands-on approach, and the ability to lead quality initiatives in a lean, fast-paced environment.

Here's How You Will Contribute

• 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.

The Ideal Candidate Will Have

Generate : Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.