Associate Manager, Quality Assurance Operations
Position Summary & Responsibilities
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.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
Position Description:
The Associate Manager, Quality Assurance Operations will provide quality oversight of external manufacturing partners to ensure compliance with cGMP requirements, regulatory commitments, and Genetix quality standards. This role will serve as a key quality liaison across internal teams (Manufacturing, MS&T, Quality Control, and Patient Supply) and CMOs, supporting risk management, deviation and change control activities, quality system review, governance forums, and performance monitoring to drive consistent, compliant, and effective operations.
Job Duties and Responsibilities:
- Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition
- Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.
- Support regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.
- Review and Approve internal and external CMO Deviations and Change Controls
- Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.
- Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.
Key Role Competencies & Evaluation Highlights
Rigorous scientific precision, unwavering commitment to regulatory compliance, and translational drug development capability.
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