Quality Assurance Ops Manager - External Manufacturing (Hybrid)

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Tuition reimbursement

Commuter benefits

Job summary

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure cGMP compliance. You will liaise with CMOs and internal teams to manage deviations, change controls, investigations, and quality systems improvements.

The role demands 4–6 years in QA within GMP biopharma, strong regulatory knowledge, and the ability to operate in a fast-paced, matrixed environment with on-site/hybrid flexibility at Somerville, MA.

Qualifications

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

Responsibilities

• Provide on-call QA support for manufacturing operations and manage quality events and risks.
• Maintain an external oversight model including QA-to-QA forums with CMOs.
• Lead deviation/lab investigation management meetings and ensure timely closure.

Skills

cGMP knowledge

Deviation & CAPA

Change Control

Lentiviral process

Cell/Gene therapy

Biologics manufacturing

Education

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

Job description

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations to oversee external manufacturing partners and ensure cGMP compliance. You will liaise with CMOs and internal teams to manage deviations, change controls, investigations, and quality systems improvements.

The role demands 4–6 years in QA within GMP biopharma, strong regulatory knowledge, and the ability to operate in a fast-paced, matrixed environment with on-site/hybrid flexibility at Somerville, MA.