Associate Director, Quality Systems

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

SUMMARY 

The Associate Director, Quality Systems is responsible for managing core elements of Genetix Biotherapeutics Quality System, including Change Control, Deviation Management, and Continuous Improvement initiatives. This role ensures that quality processes are robust, compliant with global regulatory requirements, and consistently executed to support the manufacture and release of gene therapy products.

This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.   

RESPONSIBILITIES

• Lead and oversee the end-to-end Change Control and Supplier Notification process, ensuring timely and compliant initiation, assessment, implementation, and closure.
• Manage the internal deviation and CAPA management program, ensuring investigations and corrective actions are timely, thorough, scientifically sound, and aligned with regulatory expectations.
• Maintain and monitor change control, deviation and CAPA KPIs and report to management during Quality Council.
• Serve as the SME and trainer for Change Control, Deviation and CAPA processes.
• Serve as the QA reviewer/approver of internal quality system records.
• Identify and lead continuous improvement projects to strengthen the company’s Quality System maturity and performance.
• Serve as back-up to the Sr. Director, Quality Systems, providing leadership coverage and decision-making support as needed.
• Partner with cross-functional teams to deliver tailored solutions that meet complex regulatory and quality compliance needs.
• Support internal audits and inspections.

QUALIFICATIONS 

• Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
• Minimum 8 years of experience in biotechnology, pharmaceutical, or life sciences industry, with 3 or more years in Quality Assurance.
• Experience in computerized systems management. Direct expertise using Veeva Vault platform is preferred.
• Exceptional communication, problem‑solving, and leadership skills.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.