Senior Manager, Quality Assurance Vendor & Audit Management

About the role

Genetix Biotherapeutics is seeking a Senior Manager to lead its Quality Assurance Vendor & Audit Management function. This full‑time hybrid position is based in Somerville, MA, and requires three days per week onsite. The role ensures that all GxP vendors, CMOs, CROs, laboratories, and service providers meet regulatory and company standards.

Key responsibilities

• Lead qualification, approval, re‑qualification, and ongoing monitoring of GxP vendors, CMOs, CROs, laboratories, distributors, and other service providers.
• Develop and maintain risk‑based vendor management processes, including supplier risk assessments and audit frequency determination.
• Oversee vendor performance monitoring through quality metrics, complaint trends, deviations, CAPAs, and service‑level performance.
• Maintain the Approved Vendor List (AVL) and ensure all vendor records are current.
• Partner with Procurement and business stakeholders to align supplier selection with quality requirements.
• Design and execute annual risk‑based internal and external audit programs for critical suppliers and service providers.
• Manage onsite, remote, and hybrid audits, including schedule coordination and audit record maintenance in Veeva.
• Document audit observations, approve audit reports, and track closure of findings.

Required profile

• Senior‑level professional with extensive experience in quality assurance, vendor qualification, and GxP audit programs.
• Proven ability to develop and implement risk‑based audit strategies and manage supplier performance.
• Experience collaborating with procurement and cross‑functional teams to ensure compliance with regulatory and company standards.

Required skills

• Veeva (vendor management system)