Senior QA Operations Manager – CMO Oversight

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 118,000 - 166,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition reimbursement

Paid holidays

Paid parental leave

Commuter subsidy

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking a Manager, Quality Assurance Operations to provide end-to-end QA oversight of CMOs and ensure cGMP compliance. You will partner with Manufacturing, MS&T, QC, and Patient Supply to drive risk management and change controls.

You will lead QA governance forums, review quality systems, manage Deviations and Change Controls, and maintain CMO Quality Agreements. This hybrid role requires strong leadership in a fast-paced biopharma environment.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred).
• 7+ 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 and manage quality events.
• Lead QA governance forums and joint governance meetings with CMOs.
• Review and approve Deviations and Change Controls; manage investigations.

Skills

QA Oversight

Cross-functional leadership

Risk-based decision making

Communication

Matrix environment

Education

Bachelor’s degree in Life Sciences/Engineering

7+ years QA GMP experience

Tools

Change Control systems

Deviation management

Investigation processes

Job description

Genetix Biotherapeutics in Somerville, MA is seeking a Manager, Quality Assurance Operations to provide end-to-end QA oversight of CMOs and ensure cGMP compliance. You will partner with Manufacturing, MS&T, QC, and Patient Supply to drive risk management and change controls.

You will lead QA governance forums, review quality systems, manage Deviations and Change Controls, and maintain CMO Quality Agreements. This hybrid role requires strong leadership in a fast-paced biopharma environment.