Senior QA Lead, GMP Cell & Gene Therapies

Miltenyi Biotec; San Jose (CA); On-site; USD 121,000 - 142,000; Full time

Job summary

Miltenyi Biotec is seeking a QA professional to provide quality oversight for cGMP manufacturing of advanced cell and gene therapy products. You will ensure compliance with FDA, EMA, ISO within real-time shop-floor support, batch record review, and material disposition.

The role emphasizes investigations, CAPAs, deviations, and joining cross-functional teams to maintain regulatory readiness and robust Quality Systems.

Qualifications

• Bachelor’s degree in life science and 5+ years of direct QA GMP experience.
• Experience in cell-based therapeutics or biopharmaceuticals preferred.
• Experience with Deviations, CAPAs, Change Controls and audits.
• Strong knowledge of cGMPs and regulatory requirements.

Responsibilities

• Review batch records for intermediate or final product, cell banks including in-process testing, QC release testing data packages, labeling, packaging, and all supporting documentation.
• Inspect, review, and disposition raw materials, reagents and components.
• Facilitate investigations relating to manufactured products and raw materials.
• Provide QA oversight and QA on the floor support during GMP manufacturing operations.
• Conduct line clearances, in-process inspections, support final product packaging operations.
• Assist cross-functional teams with Change Controls, Deviations, and CAPAs, providing QA input.
• Create, review and revise SOPs, study protocols, reports, and other GxP documents.
• Coordinate release of final cell-based therapeutic products for clinical and commercial use.
• Participate in audits and audit report completion; review validation/qualification packages (IQ/OQ/PQ).
• Train and provide QA guidance to internal teams on Quality Systems.

Skills

GxP knowledge

FDA/EMA/ICH/ISO regulations

QA on-the-floor oversight

Deviation/ CAPA / Change Controls

Batch record review

Audit readiness

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in life science

Tools

Quality Systems

GDP

IQ/OQ/PQ

Document control

Job description

Miltenyi Biotec is seeking a QA professional to provide quality oversight for cGMP manufacturing of advanced cell and gene therapy products. You will ensure compliance with FDA, EMA, ISO within real-time shop-floor support, batch record review, and material disposition.

The role emphasizes investigations, CAPAs, deviations, and joining cross-functional teams to maintain regulatory readiness and robust Quality Systems.