Senior QA Specialist, Digital GMP & Manufacturing

Genentech; Holly Springs (NC); On-site; USD 115,000 - 213,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech in Holly Springs, NC seeks a Principal QA Specialist to lead quality oversight for Assembly, Packaging, and Warehouse operations. You will embed Quality by Design, support continuous improvement, and ensure compliance with GMP standards while coordinating with MSAT, Operations, and Global teams.

This role emphasizes دستگاه assembly/packaging, regulatory readiness for FDA/EMA, and a digital quality footprint with SAP and MES.

Qualifications

• Bachelor’s degree in a scientific discipline; graduate or higher-level degree strongly preferred.
• 8–10 years in a GxP environment, with at least 4 years in device assembly and packaging.
• Experience with FDA/EMA inspections and regulatory compliance.
• Strong quality systems knowledge including deviation management, CAPA, and product release processes.

Responsibilities

• Provide quality oversight for Assembly, Packaging and Warehouse operations ensuring risk-based controls and Quality by Design.
• Approve procedures and drive continuous improvement of processes to maximize efficiency and compliance.
• Collaborate with MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams to maintain quality standards.

Skills

Quality Assurance

GxP

Device Assembly

Packaging

SAP

MES

Regulatory Inspections

Education

Bachelor's degree in a scientific discipline

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC seeks a Principal QA Specialist to lead quality oversight for Assembly, Packaging, and Warehouse operations. You will embed Quality by Design, support continuous improvement, and ensure compliance with GMP standards while coordinating with MSAT, Operations, and Global teams.

This role emphasizes دستگاه assembly/packaging, regulatory readiness for FDA/EMA, and a digital quality footprint with SAP and MES.