Senior Director, GxP Quality

About Generate:Biomedicines

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:

• 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 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.

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.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.