JobMesh

Associate Director, Quality Management Systems

Generate Biomedicines · Somerville, Massachusetts, US

The Role: Generate:Biomedicines is seeking a dynamic and experienced Associate Director, Quality Systems and GxP Compliance to lead our Quality Systems and C...

Job description

The Role: Generate:Biomedicines is seeking a dynamic and experienced Associate Director, Quality Systems and GxP Compliance to lead our 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. 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 - Collaboration 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...