QA Operations Lead, External Manufacturing Oversight

Doist; Somerville (MA); Hybrid; USD 115,000 - 125,000; Full time

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking an Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure cGMP compliance.

You will serve as a QA liaison across Manufacturing, MS&T, Quality Control, and CMOs, managing deviations, change controls, investigations, and product complaints.

This full-time hybrid role requires 3 days on-site, with strong leadership, risk management, and a focus on continuous improvement of quality systems and metrics.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred).
• 4–6 years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing.
• Strong experience supporting CMO oversight and external manufacturing environments.

Responsibilities

• Provide on-call QA support for manufacturing operations, identifying and mitigating quality events and risks.
• Maintain an external oversight model, leading QA-to-QA forums and governance with CMOs.
• Support regular Deviation/Lab Investigation Management meetings ensuring compliance and timeliness.
• Review and approve internal/external CMO Deviations and Change Controls.
• Serve as QA contact for Product Complaints with investigations and closure.
• Monitor CMO quality performance metrics and drive continuous improvement initiatives.

Skills

cGMP regulations

Deviation / CAPA

Change Control

Validation lifecycle

Lentiviral vector process

Process validation

Cell/gene therapy manufacturing

ICH guidelines

Education

Bachelor’s degree in Life Sciences, Engineering, or related discipline

Job description

Genetix Biotherapeutics in Somerville, MA is seeking an Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure cGMP compliance.

You will serve as a QA liaison across Manufacturing, MS&T, Quality Control, and CMOs, managing deviations, change controls, investigations, and product complaints.

This full-time hybrid role requires 3 days on-site, with strong leadership, risk management, and a focus on continuous improvement of quality systems and metrics.