QA Operations Manager, GMP & CMO Oversight

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations in Somerville, MA. This full-time hybrid role focuses on quality oversight of external manufacturing partners to ensure cGMP compliance and alignment with Genetix quality standards.

You will coordinate with Manufacturing, MS&T, Quality Control, and patient supply teams, lead deviation/change control activities, and drive risk management and continuous improvement across the product lifecycle.

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 and mitigate quality risks.
• Maintain external oversight model and guide quality discussions with CMOs.
• Support Deviation/Lab Investigation Management meetings for compliance and timeliness.
• Review and Approve internal and external CMO Deviations and Change Controls.
• Serve as QA reviewer/approver for validation protocols and reports.
• Monitor CMO quality performance metrics and drive improvements.
• Author and review Annual Product Quality Reviews (APQRs).
• Represent QA Operations in Manufacturing Tier and CCRB meetings.

Skills

cGMP knowledge

Regulatory compliance

QA oversight

Deviation management

Change control

CMO oversight

Cross-functional collaboration

Risk management

Quality systems

Investigation skills

Education

Bachelor’s degree in Life Sciences/Engineering

Tools

Quality systems software

Job description

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations in Somerville, MA. This full-time hybrid role focuses on quality oversight of external manufacturing partners to ensure cGMP compliance and alignment with Genetix quality standards.

You will coordinate with Manufacturing, MS&T, Quality Control, and patient supply teams, lead deviation/change control activities, and drive risk management and continuous improvement across the product lifecycle.