Principal QA Specialist - Lead Quality in Next-Gen Medicine

Regulatory Jobs; 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 seeking a highly impactful Principal QA Specialist to lead quality oversight for cartridge filling, inspections, assembly and packaging, partnering across MSAT, Operations, Quality, QC and Global teams to ensure strict GMP compliance.

You will embed Quality by Design, drive CAPA and investigations, and support regulatory inspections to establish Holly Springs as a center of excellence for aseptic drug product manufacturing.

Qualifications

• Bachelor’s degree in a scientific discipline; graduate preferred.
• 8–10 years in a GxP environment with cartridge sterile drug product manufacturing experience in QA Ops or MSAT.
• Advanced GMP and quality regulation knowledge; experience with global regulatory inspections (FDA/EMA).
• Experience leading complex investigations and strong technical writing skills.
• Expertise in deviation management, CAPA, and product release processes.
• Hands-on with SAP and MES; able to translate business processes into digital recipes.

Responsibilities

• Provide quality oversight for filling, inspections, assembly and packaging.
• Collaborate with MSAT, Operations, Warehouse, Engineering, Quality, QC and Global teams to ensure quality standards.
• Embed quality into site design; support continuous improvement and operational excellence.
• Design and approve Release by Exception logic for accelerated batch disposition.
• Support equipment/process design reviews, FAT, SAT and commissioning activities.
• Lead complex investigations, identify root causes and implement CAPAs.
• Act as SME for Filling, Inspection, Assembly, Packaging and clean utilities; monitor data and trends.
• Support inspection readiness and regulatory inspections; review dossier sections.

Skills

Quality Assurance

GxP experience

CAPA oversight

Deviation management

Regulatory inspections

Continuous improvement

Investigations

Data integrity

Education

Bachelor’s degree in science

Tools

SAP

MES

Job description

Genentech in Holly Springs, NC is seeking a highly impactful Principal QA Specialist to lead quality oversight for cartridge filling, inspections, assembly and packaging, partnering across MSAT, Operations, Quality, QC and Global teams to ensure strict GMP compliance.

You will embed Quality by Design, drive CAPA and investigations, and support regulatory inspections to establish Holly Springs as a center of excellence for aseptic drug product manufacturing.