Senior QA Architect - Cartridge Filling & Packaging

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, is hiring a Principal QA Specialist to drive quality for cartridge filling, inspections, assembly, packaging, and clean utilities. You will embed QbD, manage deviations and CAPA, and partner with MSAT, Operations, and Global teams to ensure compliance with GMP standards.

The role emphasizes continuous improvement, regulatory readiness, and a strong quality culture as the site launches, with relocation benefits available and a competitive salary range based on

Qualifications

• Bachelor's degree in a scientific discipline required; graduate degree preferred.
• 8–10 years in a GxP environment with cartridge sterile drug product manufacturing experience.
• Strong compliance mindset and strategic, systems-thinking approach.
• Experience with global regulatory inspections (FDA/EMA).

Responsibilities

• Establish and implement risk-based Quality by Design for filling to packaging.
• Approve procedures and drive continuous improvement.
• Collaborate with MES and SAP for recipes and batch records.
• Design Release by Exception logic for batch disposition.
• Support PQ through design reviews, FAT/SAT, commissioning.
• Lead investigations, CAPA, and deviations.
• Act as QA expert for filling, inspection, assembly, packaging, and clean utilities.
• Support inspection readiness and regulatory reviews.
• Ensure compliance with Annex 1 and regulatory requirements.
• Oversee manufacturing processes and digital documentation.

Skills

Quality Assurance

GxP

Regulatory compliance

CAPA

Investigations

Continuous Improvement

Education

Bachelor's degree in a scientific discipline

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC, is hiring a Principal QA Specialist to drive quality for cartridge filling, inspections, assembly, packaging, and clean utilities. You will embed QbD, manage deviations and CAPA, and partner with MSAT, Operations, and Global teams to ensure compliance with GMP standards.

The role emphasizes continuous improvement, regulatory readiness, and a strong quality culture as the site launches, with relocation benefits available and a competitive salary range based on