Senior QA Manager, Cell Therapy & CDMO Oversight

Kamau Therapeutics, Inc.; South San Francisco (CA); Presencial; USD 145.000 - 195.000; Jornada completa

Descripción de la vacante

Kamau Therapeutics, Inc. in the South San Francisco and Redwood Shores area is seeking an experienced Senior QA Manager to lead investigations, CAPA, change control, supplier quality, and MRB activities in a GMP cell therapy setting.

You will be the on-site QA presence at CDMOs and suppliers, partner with Manufacturing, Regulatory Affairs, and cross-functional teams to drive risk-based decisions, mentor junior staff, and advance continuous quality improvements across outsourced manufacturing.

Formación

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 8+ years of QA in regulated industries (pharma/biotech/cell therapy).
• Hands-on quality investigations, CAPA, change control, supplier quality, batch release and MRB.

Responsabilidades

• Lead investigations into deviations, OOS/OOT, complaints, and non-conformances with structured problem-solving.
• Own the CAPA program including effectiveness checks and trending.
• Manage change control for facility, equipment, process, and documentation changes.
• Oversee supplier qualification, audits, SCARs, and supplier quality programs.
• Provide on-site QA oversight at CDMO and supplier sites across manufacturing campaigns.

Conocimientos

Quality Assurance

GMP

CAPA

Root Cause Analysis

CDMO Coordination

On-site QA

Leadership

Regulatory Liaison

Educación

Bachelor's degree in Life Sciences

Advanced degree a plus

Herramientas

TrackWise

MasterControl

Veeva QMS

Descripción del empleo

Kamau Therapeutics, Inc. in the South San Francisco and Redwood Shores area is seeking an experienced Senior QA Manager to lead investigations, CAPA, change control, supplier quality, and MRB activities in a GMP cell therapy setting.

You will be the on-site QA presence at CDMOs and suppliers, partner with Manufacturing, Regulatory Affairs, and cross-functional teams to drive risk-based decisions, mentor junior staff, and advance continuous quality improvements across outsourced manufacturing.