Principal QA Specialist (Multi-dose pens), 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 related to cartridge filling, inspection, assembly, and packaging at Genentech’s Holly Springs, North Carolina facility. The role manages end-to-end quality for these areas, working with MSAT, Operations, Warehouse, Engineering, Quality, QC, and global teams to ensure adherence to quality standards, global regulatory requirements, and internal standards. The position supports embedding quality into site operations, continuous improvement, and operational excellence in accordance with Good Manufacturing Practices, with a focus on aseptic drug product manufacturing. The role supports operational procedure development and implementation, risk-based controls, process and procedure improvement, and the design of digital manufacturing recipes and batch records. It also develops Release by Exception logic, participates in equipment and process design reviews, FAT, SAT, and commissioning, and supports or leads complex investigations and CAPAs. As a technical expert, the specialist provides guidance on filling, inspection, assembly, packaging, and clean utilities; supports inspection readiness and regulatory inspections; participates in risk assessments and change controls; and provides direct quality oversight of manufacturing processes, cleanroom practices, sterilization, labeling, serialization, and validation. The role also serves as Quality Assurance Owner and approver for applications supporting digital shop-floor processes. The position is based in Holly Springs, North Carolina. 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.
At least 8–10 years of experience 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.
Experience embedding 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.
Experience in cartridge sterile drug product manufacturing in a manufacturing, QA Operations, or MSAT role.

Responsibilities

Provide quality oversight for cartridge filling, inspection, assembly, packaging, and supporting processes.
Manage end-to-end quality for assigned manufacturing areas in collaboration with MSAT, Operations, Warehouse, Engineering, Quality, QC, and global teams.
Support establishment and implementation of operational procedures and risk-based controls for processes from cartridge filling through packaging.
Approve procedures and assess and refine processes to drive continuous improvement and 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 and define critical process parameters for automatic verification supporting accelerated 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 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 improvement opportunities.
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, labeling, serialization, and validation activities.
Serve as Quality Assurance Owner and approver for applications that enable digital transformation of shop-floor processes.