Director, Quality Systems and GxP Compliance

Director, Quality Systems and GxP Compliance

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.

About the Role

Generate : Biomedicines is seeking a dynamic and experienced Director, Quality Systems and GxP Compliance to lead our Quality Systems and Compliance operations across the organization. This role will oversee core quality management functionsincluding training, documentation, change control, deviations, CAPAs, audits, complaints, and supplier managementensuring GxP compliance and inspection readiness. Reporting to the Head of Quality, this individual will manage and develop the Quality Systems and Compliance team while collaborating with site leadership to uphold GB's commitment to regulatory excellence and operational efficiency.

This is a unique opportunity to shape and strengthen Quality systems in a fast-paced biotech environment, supporting innovative therapies from development through commercialization.

Here's how you'll contribute :

• Quality Systems Leadership : Serve as the Quality Lead for Quality Systems and Compliance, providing strategic oversight and guidance across the company.
• Coordination with other Quality functions : This role will be focused on Quality Systems, Quality Operations, and GxP compliance, across the enterprise. Subject matter expertise in the other GxP disciplines (e.g., GLP, GDP, GPvP, etc.) is particularly valuable.
• QMS Operations : Oversee GxP operations, including change controls, deviations, CAPAs, complaints, audits, and supplier management, ensuring timely and accurate documentation and closure.
• Implementation, validation, training and maintenance of Veeva Quality Management System
• Complaint Handling : Ensure efficient intake, documentation, triage, escalation, and reconciliation of product complaints with related systems and departments.
• GxP Training : Manage training assignments through GB's training system, monitor compliance, and generate training completion metrics.
• System Validation : Support validation efforts for new or updated GxP IT systems, including document review, execution of test scripts, and change control support.
• Metrics & Reporting : Compile and present Quality and supplier metrics for periodic Quality Management Review meetings.
• Audit Program : Implement and oversee GB's internal audit program to ensure continuous compliance and readiness for regulatory inspections.
• Continuous Improvement : Lead initiatives to enhance QMS efficiency and effectiveness, embedding a culture of continuous improvement.
• Regulatory Support : Support regulatory submissions (e.g., annual reports, IND / CTA updates, marketing authorizations) by providing quality documentation and input.
• Leadership & People Management : Manage and develop the Quality Systems and Compliance team, fostering accountability, growth, and engagement.
• Collaboration : Partner with the Head of Quality, Head of Regulatory, Head of Clinical Operations, Head of IT, Head of Manufacturing and site leadership to ensure alignment with corporate goals, customer expectations, and global regulatory obligations (FDA, EMA, and other agencies).

Leadership Responsibilities

The Ideal Candidate will have :

Location / Work Type

Hybrid- 2-3 days a week onsite in Somerville, MA. This is not a fully remote role.

Why join us : This is a unique opportunity to lead Quality Systems in a company pioneering Generative Biology, where machine learning and biology converge to create breakthrough medicines. At Generate : Biomedicines, you will join a collaborative, mission-driven team that values innovation, inclusivity, and impactworking together to transform therapeutic development and patient care.

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.