Associate Director, Quality Management Systems

Generate Biomedicines•Somerville, MA

3h•Hybrid

About The Position

Generate:Biomedicines is seeking a dynamic and experienced Associate Director, Quality Systems and GxP Compliance to lead Quality Systems and Compliance operations across the organization. This role will oversee core quality management functions, including training, documentation, change control, deviations, CAPAs, audits, complaints, and supplier management, ensuring GxP compliance and inspection readiness. Reporting to the Vice President, Quality, this individual will manage and develop the Quality Systems while collaborating with site stakeholders 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. Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. They are advancing a new approach to drug creation grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, the company is advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities, unifying computational design and clinical development within a single operating model to translate this approach into clinical-stage programs.

Requirements

B.S. with significant relevant experience is required
10+ years of Quality experience in biotech/pharma, with a strong background in GxP compliance and Quality Systems
Proven track record in leading QMS operations and managing audits, complaints, and regulatory submissions
Prior experience partnering closely with key stakeholders in Technical Operations, Regulatory, Clinical Operations, Biometrics, etc.
Experience implementing Veeva or other Quality Management Systems
Experience working with global regulatory agencies (FDA, EMA, and other authorities)
Demonstrated success in building and managing high-performing teams
Excellent project management, organizational, and communication skills
Strong problem-solving mindset, with the ability to navigate ambiguity and drive continuous improvement

Nice To Haves

Advanced degree in a scientific or technical discipline preferred
Subject matter expertise in the other GxP disciplines (e.g., GLP, GMP, GDP, GVP, etc.) is particularly valuable

Responsibilities

Serve as the Quality Lead for Quality Systems and Compliance, providing strategic oversight and guidance across the company
Collaboration with other Quality functions
Focus on Quality Systems, Quality Operations, and GxP compliance, across the enterprise
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
Ensure efficient intake, documentation, triage, escalation, and reconciliation of product complaints with related systems and departments
Manage training assignments through GB’s training system, monitor compliance, and generate training completion metrics
Support validation efforts for new or updated QMS systems, including document review, execution of test scripts, and change control support
Compile and present Quality and supplier metrics for periodic Quality Management Review meetings
Implement and oversee GB’s internal audit program to ensure continuous compliance and readiness for regulatory inspections
Lead initiatives to enhance QMS efficiency and effectiveness, embedding a culture of continuous improvement
Support regulatory submissions (e.g., annual reports, IND/CTA updates, marketing authorizations) by providing quality documentation and input
Manage and develop the Quality Systems and Compliance team, fostering accountability, growth, and engagement
Partner with Quality, Regulatory, Clinical Operations, IT, Manufacturing and site leadership to ensure alignment with corporate goals, customer expectations, and global regulatory obligations (FDA, EMA, and other agencies)