Principal QA Specialist (Multi-dose pens), CVRM

Genentech•Cary, NC

11h•$114,700 - $212,900

About The Position

The Principal QA Specialist will provide quality oversight for manufacturing and supporting processes, specifically cartridge filling, inspection, assembly, and packaging, at Roche/Genentech’s Holly Springs, North Carolina facility. The role manages end-to-end quality in these areas and works closely with MSAT, Operations, Warehouse, Engineering, Quality, QC, and global teams to ensure adherence to quality standards and regulatory requirements. It is an opportunity to embed quality into the site’s operational design, support continuous improvement, and advance operational excellence in accordance with Good Manufacturing Practices. The specialist supports the establishment of risk-based operational procedures and controls, approves procedures, and drives process improvement. The role also works with MES and SAP teams on digital recipes and Manufacturing Batch Records, designs Release by Exception logic, supports equipment and process design reviews and commissioning, and leads or supports complex investigations and CAPAs. As a subject matter expert, the specialist provides guidance on filling, inspection, assembly, packaging, and clean utilities; supports regulatory inspections and dossier reviews; and oversees manufacturing processes and related digital applications as the Quality Assurance Owner and approver.

Requirements

Bachelor’s degree in a scientific discipline.
Minimum of 8–10 years in a GxP environment.
At least 4 years of cartridge sterile drug product manufacturing experience in manufacturing, QA Operations, or MSAT.
Advanced knowledge of GMP and quality regulations, with experience participating in global regulatory inspections such as FDA and EMA inspections.
Demonstrated Quality Assurance expertise and successful oversight of critical quality systems, including deviation management, CAPA, and product release processes.
Experience leading complex investigations and strong technical writing skills.
Ability to embed operational excellence in complex, large-scale manufacturing environments.
Experience implementing and driving a continuous improvement culture.
Good understanding of Annex 1 and how to comply with its requirements operationally.
Hands-on experience with SAP and MES, including the ability to explain how a business process translates into a digital recipe.
Ability to work in a dynamic, fast-paced environment while maintaining high quality and safety standards.

Nice To Haves

Graduate or higher-level degree.
Strategic and systems thinking, compliance focus, ability to anticipate technology trends, and skill in driving operational excellence through operationally implementable solutions.

Responsibilities

Support the establishment and implementation of risk-based operational procedures for cartridge filling through packaging, embedding Quality by Design into processes.
Approve procedures and drive continuous improvement by assessing and refining processes and procedures.
Work with MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
Design Release by Exception logic, defining critical process parameters for automatic verification and accelerated batch disposition.
Support equipment and process design reviews, FAT, SAT, and commissioning to develop fit-for-purpose operational processes ahead of PQ.
Support or lead complex investigations, determine root causes, implement effective Corrective and Preventive Actions, and approve Deviations and CAPAs.
Serve as a subject matter expert for Filling, Inspection, Assembly, Packaging, and clean utilities; monitor data and trends and identify improvements.
Support inspection readiness, participate in regulatory inspections, and support review and approval of dossier sections.
Participate in equipment and process risk assessments, approve change controls, and act as local Quality Product Owner.
Provide direct oversight of filling, visual inspection, device assembly, packaging, clean utility generation and distribution, cleanroom processes and behaviors, sterilization cycles, labelling, serialization, and validation activities.
Serve as Quality Assurance Owner and approver for applications supporting digital transformation of shop-floor processes.