Hybrid QA Operations Lead, External Manufacturing

Regulatory Toolkit; Somerville (MA); Híbrido; USD 115.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term incentive

Comprehensive benefits package

On-site parking

Descripción de la vacante

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations to provide QA oversight of external manufacturing partners, ensuring cGMP compliance and alignment with Genetix quality standards. You will liaise across Manufacturing, MS&T, QC, and Patient Supply, supporting deviations, change control, and risk management.

The role focuses on governance forums, performance monitoring, and continuous improvement within a fast-paced, matrixed CMO environment.

Formación

• Bachelor’s degree 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 CMO oversight and external manufacturing environments.

Responsabilidades

• Provide QA oversight of external manufacturing partners to ensure cGMP compliance.
• Lead QA forums and governance meetings with CMOs.
• Review Deviations, Change Controls, and investigations with a focus on timely closure.
• Serve as QA contact for product complaints and risk assessments.
• Monitor CMO performance metrics and drive continuous improvement.

Conocimientos

cGMP regulations

Deviation handling

CAPA processes

Change Control

Validation lifecycle

Quality governance

Educación

Bachelor’s degree in Life Sciences/Engineering

Herramientas

CMO oversight

GMP quality systems

Descripción del empleo

Genetix Biotherapeutics is seeking an Associate Manager, Quality Assurance Operations to provide QA oversight of external manufacturing partners, ensuring cGMP compliance and alignment with Genetix quality standards. You will liaise across Manufacturing, MS&T, QC, and Patient Supply, supporting deviations, change control, and risk management.

The role focuses on governance forums, performance monitoring, and continuous improvement within a fast-paced, matrixed CMO environment.