Senior QA: Vendor & Audit Compliance Lead

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Parental leave

Commuter subsidy

Job summary

Genetix Biotherapeutics is seeking a Senior Manager, QA Compliance to lead vendor qualification, supplier oversight, and GxP audit programs. This hybrid role is based in Somerville, MA with onsite presence three days per week, and candidates must reside within commuting distance.

You will oversee AVL maintenance, supplier risk assessments, and audit execution across CMOs, CROs, laboratories, and logistics providers, ensuring regulatory readiness and continuous quality improvement.

Qualifications

• Bachelor's degree in Life Sciences or related field plus 8–10 years in QA/Compliance.
• Extensive experience managing GxP audits and supplier oversight.
• Proven ability to lead teams and drive regulatory readiness.

Responsibilities

• Lead qualification, approval, requalification, and monitoring of GxP vendors and CMOs.
• Develop risk-based vendor management processes and audit strategies.
• Oversee supplier performance metrics, CAPAs, and deviations.
• Review vendor qualification packages and ensure regulatory alignment.
• Partner with Procurement and stakeholders to select compliant suppliers.
• Develop and execute annual internal and external audit programs.
• Present audit trends and compliance risks to senior leadership.
• Drive continuous improvement in supplier oversight and audit processes.

Skills

Vendor management

Quality Assurance

GxP auditing

Leadership

Regulatory compliance

Audit management

Education

Bachelor's degree in Life Sciences

Job description

Genetix Biotherapeutics is seeking a Senior Manager, QA Compliance to lead vendor qualification, supplier oversight, and GxP audit programs. This hybrid role is based in Somerville, MA with onsite presence three days per week, and candidates must reside within commuting distance.

You will oversee AVL maintenance, supplier risk assessments, and audit execution across CMOs, CROs, laboratories, and logistics providers, ensuring regulatory readiness and continuous quality improvement.