QA Operations Manager, CMO Quality & Compliance

Genetix Biotherapeutics Inc.; Somerville, Northern (MA, KY); Hybrid; USD 118,000 - 166,000; Full time

Job summary

Genetix Biotherapeutics is seeking a Manager, Quality Assurance Operations to provide end-to-end quality oversight of CMOs, ensuring compliance with cGMP and Genetix standards. You will partner with Manufacturing, MS&T, Quality Control, and Patient Supply as the primary QA interface with external partners.

You will lead QA governance, review quality systems, and drive proactive risk management, deviation handling, and change control lifecycle across the product lifecycle in a fast-paced

Qualifications

• 7+ years of experience in Quality Assurance within GMP-regulated biopharmaceutical manufacturing.
• Strong experience supporting CMO oversight and external manufacturing environments.
• Deep knowledge of cGMP regulations, Deviation, CAPA, and investigation processes.
• Knowledge of process validation and cell/gene therapy manufacturing is preferred.

Responsibilities

• Provide end-to-end QA oversight of CMOs to ensure compliance with cGMP and Genetix standards.
• Lead QA forums and governance with external partners and internal teams.
• Manage Deviation/Lab Investigation and Change Control lifecycle activities.
• Review and approve deviations, change controls, and validation deliverables.
• Serve as QA point-of-contact for product complaints and risk assessments.
• Monitor quality metrics and drive continuous improvement across sourcing and manufacturing.

Skills

Quality Assurance

Regulatory compliance

Risk management

Communication

Cross-functional collaboration

Education

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

Job description

Genetix Biotherapeutics is seeking a Manager, Quality Assurance Operations to provide end-to-end quality oversight of CMOs, ensuring compliance with cGMP and Genetix standards. You will partner with Manufacturing, MS&T, Quality Control, and Patient Supply as the primary QA interface with external partners.

You will lead QA governance, review quality systems, and drive proactive risk management, deviation handling, and change control lifecycle across the product lifecycle in a fast-paced