Senior QA Lead - Aseptic CVRM Manufacturing

Regulatory Jobs; Holly Springs (NC); On-site; USD 94,000 - 175,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Genentech in Holly Springs, NC, is hiring two Senior QA Specialist roles to oversee manufacturing and warehouse activities with a strong compliance mindset. The roles require ensuring quality, leading investigations, and coordinating with cross-functional teams to meet global regulatory standards.

The positions emphasize embedding quality into site operations, supporting continuous improvement, and preparing for aseptic drug product manufacturing excellence.

Qualifications

• Minimum 6–8 years in a GxP environment, with 3+ years in QA Operations, Manufacturing, or MSAT for sterile drug product manufacturing or device assembly.
• Proven oversight of major deviations, root cause analysis, complex investigations, and CAPA effectiveness.

Responsibilities

• Provide QA oversight for manufacturing and warehouse operations, and collaborate with cross-functional partners to ensure quality standards.
• Lead or support investigations, determine root causes, and ensure corrective actions are implemented.
• Participate in change controls, process parameter optimizations, and continuous improvement projects.
• Perform incoming goods and finished product releases and final disposition reviews for shipments.
• Approve site procedures and drive SOP improvements and efficiency.
• Support inspection readiness and participate in regulatory inspections.
• Extend QA guidance to MSAT, IT/OT, Supply Chain, and Facilities/Engineering.

Skills

Quality Assurance

Deviation investigations

CAPA effectiveness

Regulatory inspections

GxP systems

SAP

MES

Data integrity

Quality risk management

Continuous improvement

Education

Bachelor's degree in science or engineering

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC, is hiring two Senior QA Specialist roles to oversee manufacturing and warehouse activities with a strong compliance mindset. The roles require ensuring quality, leading investigations, and coordinating with cross-functional teams to meet global regulatory standards.

The positions emphasize embedding quality into site operations, supporting continuous improvement, and preparing for aseptic drug product manufacturing excellence.