Principal QA Specialist (Assembly & Packaging), CVRM

Genentech•Holly Springs, NC

2d•Onsite

About The Position

Genentech is seeking a Principal QA Specialist to provide quality oversight for manufacturing and supporting processes, with a focus on Assembly, Packaging, and Warehouse operations at its 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 compliance with quality standards and regulatory requirements. The position supports the establishment of operational procedures and risk-based controls, embeds Quality by Design, approves procedures, and drives continuous improvement. It also contributes to digital quality systems and shop-floor transformation, including MES and SAP recipes, Manufacturing Batch Records, validated master data, and Release by Exception logic. The specialist supports design reviews, FAT, SAT, commissioning, investigations, inspections, risk assessments, and change controls, and provides direct oversight of device assembly, packaging, labeling, serialization, validation, warehouse operations, and material movement. The role is part of a fast-paced, high-accountability environment preparing to launch a new drug product manufacturing facility in 2028. Relocation benefits are available. The expected salary range for the Holly Springs location is $114,700–$212,900, with actual pay determined by experience, qualifications, location, and other job-related factors. 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, including experience participating in global regulatory inspections such as FDA and EMA inspections.
Quality Assurance experience overseeing 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.
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.
Experience with pre-filled syringes or autoinjectors.

Responsibilities

Provide quality oversight for Assembly, Packaging, and Warehouse operations and supporting processes.
Support the establishment and implementation of operational procedures and risk-based controls to embed Quality by Design.
Approve procedures and regularly assess and refine processes to improve efficiency and effectiveness.
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 by defining critical process parameters for automatic verification and accelerated batch disposition.
Support equipment and process design reviews, FAT, SAT, and commissioning activities.
Support or lead complex investigations, determine root causes, and ensure effective Corrective and Preventive Actions are implemented.
Approve deviations and CAPAs.
Serve as a subject matter expert for Assembly and Packaging, monitor data and trends, and identify improvement opportunities.
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, process support operations, labeling, serialization, validation activities, warehouse operations, and material movement.
Serve as the Quality Assurance Owner and approver for applications supporting the digital transformation of shop-floor processes.