Principal QA Specialist (Assembly & Packaging), CVRM

Genentech•Cary, NC

11h•$114,700 - $212,900•Onsite

About The Position

The Principal QA Specialist provides quality oversight for manufacturing and supporting processes, specifically Assembly, Packaging, and Warehouse operations, at Roche/Genentech’s Holly Springs, North Carolina facility. The role manages end-to-end quality for these areas and collaborates with MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams to ensure compliance with quality standards, global regulatory requirements, and Roche’s internal standards. The position supports embedding quality into operational design, continuous improvement, and operational excellence in accordance with Good Manufacturing Practices. Responsibilities span operational procedures and risk-based controls, quality system approvals, digital manufacturing systems, Release by Exception, equipment and process design and commissioning, investigations, inspection readiness, and direct oversight of assembly, packaging, and warehouse processes. The role also serves as the Quality Assurance Owner and approver for applications supporting the digital transformation of shop-floor processes. The facility is a planned high-volume drug product manufacturing site in Holly Springs, North Carolina, with a planned launch in 2028. Relocation benefits are available. The expected salary range is $114,700–$212,900, and a discretionary annual bonus may be available based on individual and Company performance.

Requirements

Bachelor’s degree in a scientific discipline.
Minimum of 8–10 years of experience in a GxP environment.
At least 4 years of device assembly and packaging experience in manufacturing, QA Operations, or MSAT.
Advanced knowledge of GMP and quality regulations, with experience participating in global regulatory inspections, including FDA and EMA inspections.
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.
Experience embedding operational excellence in complex, large-scale manufacturing environments.
Experience implementing and driving a continuous improvement culture.
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 ensuring quality and safety standards.

Nice To Haves

Graduate or higher-level degree in a scientific discipline.
Experience with pre-filled syringes or autoinjectors.
Strategic and systems-thinking skills, a compliance focus, ability to anticipate technology trends, and ability to deliver operationally implementable solutions.

Responsibilities

Support establishment and implementation of operational procedures for Assembly, Packaging, and Warehouse operations, ensuring appropriate risk-based controls and embedding Quality by Design.
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 to support accelerated batch disposition.
Support equipment and process design reviews, FAT, SAT, and commissioning activities to develop fit-for-purpose, lean operational processes before PQ.
Support or lead complex investigations, determine root causes, ensure effective Corrective and Preventive Actions, and approve Deviations and CAPAs.
Act as a subject matter expert for Assembly and Packaging, monitor data and trends, and identify areas for improvement.
Support inspection readiness, participate in regulatory inspections, and support review and approval of dossier sections.
Participate in equipment and process risk assessments and approve change controls.
Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization, validation activities, warehouse operations, and material movement throughout the facility.
Serve as the Quality Assurance Owner and approver for applications supporting the digital transformation of shop-floor processes and replacing traditional paper documentation.