QA Operations Lead, External Manufacturing

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

Benefits offered by this job

Health insurance

Life insurance

Disability insurance

401(k) match

Flexible time-off

Tuition reimbursement

Parental leave

Parking

Job summary

Genetix Biotherapeutics Inc. is seeking an Associate Manager, Quality Assurance Operations to provide quality oversight of external manufacturing partners and ensure compliance with cGMP requirements and regulatory commitments.

In this hybrid role (three days per week) in Somerville, MA, you will partner with Manufacturing, MS&T, Quality Control, and CMOs to drive risk management, deviations, change controls, and performance monitoring for compliant operations.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 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.
• Deep knowledge of cGMP regulations (FDA, ICH guidelines)

Responsibilities

• Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks.
• Maintain a consistent external oversight model, including leading QA-to-QA forums and guiding quality discussions with CMOs.
• Support Deviation/Lab Investigation Management meetings, ensuring compliance and timeliness.
• Review and Approve internal and external CMO Deviations and Change Controls.
• Serve as QA point-of-contact for Product Complaints, ensuring investigation and closure.
• Perform Quality Impact Assessments for Change Controls, ensuring risk evaluation and mitigation.
• Represent QA Operations in Manufacturing Tier meetings and CCRB meetings.
• QA reviewer/approver for validation protocols/reports and related deliverables.
• Monitor CMO quality performance metrics and drive continuous improvement initiatives.
• Own and manage CMO Quality Agreements to ensure compliance.
• Author/review Annual Product Quality Reviews (APQRs).
• Identify trends and opportunities for improvement across the product lifecycle.

Skills

CMO oversight

cGMP knowledge

Deviation & CAPA

Change control

Regulatory compliance

Cross-functional leadership

Education

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

Job description

Genetix Biotherapeutics Inc. is seeking an Associate Manager, Quality Assurance Operations to provide quality oversight of external manufacturing partners and ensure compliance with cGMP requirements and regulatory commitments.

In this hybrid role (three days per week) in Somerville, MA, you will partner with Manufacturing, MS&T, Quality Control, and CMOs to drive risk management, deviations, change controls, and performance monitoring for compliant operations.