QA Compliance Lead — Vendor & Audit Management

Regulatory Toolkit; Somerville (MA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) plan

Commuter subsidy

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking a Senior Manager, QA Compliance - Vendor & Audit Management to lead vendor qualification, supplier oversight, and GxP audit programs. The role develops risk-based audit strategies, drives supplier quality improvements, and sustains inspection readiness across the organization.

Responsibilities include managing qualification and requalification of vendors, CMOs, CROs, and labs; leading internal and external audits (onsite/remote/hybrid);

Qualifications

• Bachelor's degree in Life Sciences or related field and 8–10 years QA experience.
• Extensive experience managing GxP audits and supplier oversight.
• Experience aligning QA programs with regulatory expectations (FDA/EMA).

Responsibilities

• Lead vendor qualification, approval and monitoring of GxP vendors and CMOs.
• Develop risk-based vendor management processes and audit frequencies.
• Develop and execute internal and external audit programs (onsite/remote/hybrid).
• Review audit reports, CAPAs, and ensure timely closure.
• Negotiate and manage Quality Agreements with suppliers and legal teams.
• Provide leadership to QA Compliance professionals and drive KPIs.

Skills

QA Compliance

Vendor qualification

Audit management

GxP audits

Leadership

Regulatory affairs

Education

Bachelor's degree

Tools

Veeva

Job description

Genetix Biotherapeutics in Somerville, MA is seeking a Senior Manager, QA Compliance - Vendor & Audit Management to lead vendor qualification, supplier oversight, and GxP audit programs. The role develops risk-based audit strategies, drives supplier quality improvements, and sustains inspection readiness across the organization.

Responsibilities include managing qualification and requalification of vendors, CMOs, CROs, and labs; leading internal and external audits (onsite/remote/hybrid);