Principal QA Specialist (Assembly & Packaging), CVRM

Roche•Holly Springs, NC

1d•$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, managing end-to-end quality for these areas in collaboration with MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams. The role helps embed quality into the site's operational design, supports continuous improvement, and drives operational excellence in accordance with Good Manufacturing Practices and global regulatory requirements. The position supports the establishment and implementation of risk-based operational procedures; approves procedures and promotes process improvement; works with MES and SAP teams on digital recipes and Manufacturing Batch Records; and designs Release by Exception logic. It also supports equipment and process design reviews, FAT, SAT, commissioning, investigations, inspections, risk assessments, and change controls. The role provides direct oversight of device assembly, packaging, labelling, serialization, validation activities, warehouse operations, and material movement. It serves as Quality Assurance Owner and approver for applications supporting digital shop-floor processes. The role is based at Genentech's Holly Springs, North Carolina facility, a planned high-volume drug product manufacturing site with a planned launch in 2028. Relocation benefits are available. The expected salary range is $114,700–$212,900, with a discretionary annual bonus potentially 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.
Experience participating in global regulatory inspections, including 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, 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 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 manufacturing and supporting processes.
Support the establishment and implementation of operational procedures with appropriate risk-based controls and Quality by Design principles.
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 in batch disposition.
Support equipment and process design reviews, FAT, SAT, and commissioning activities ahead of PQ.
Support or lead complex investigations, determine root causes, implement effective CAPAs, and 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, packaging, process support operations, labelling, serialization, validation activities, warehouse operations, and material movement.
Serve as Quality Assurance Owner and approver for applications that enable digital shop-floor processes.