Senior Manager, Quality Assurance Vendor & Audit Management
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 based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.
Position Description
The Senior Manager, QA Compliance - Vendor & Audit Management is responsible for leading the Genetix's vendor qualification, supplier oversight, and GxP audit programs to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role oversees the lifecycle management of suppliers, contract manufacturing organizations (CMOs), contract research organizations (CROs), laboratories, treatment centers, and other GxP service providers. The individual develops and maintains a risk-based audit strategy, drives supplier quality improvements, and supports inspection readiness across the organization.
Job Duties and Responsibilities
Vendor Qualification & Oversight
- Lead the qualification, approval, requalification, and monitoring of GxP vendors, suppliers, CMOs, CROs, laboratories, distributors, and service providers.
- Develop and maintain risk-based vendor management processes and procedures.
- Perform supplier risk assessments to determine qualification requirements and audit frequency.
- Oversee vendor performance monitoring, including quality metrics, complaint trends, deviations, CAPAs, and service level performance.
- Maintain the Approved Vendor List (AVL) and en
Key Role Competencies & Evaluation Highlights
Rigorous scientific precision, unwavering commitment to regulatory compliance, and translational drug development capability.
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