Principal QA Specialist (Manufacturing QA), CVRM

Genentech•Holly Springs, NC

1d•Onsite

About The Position

Two Principal QA Specialist positions are available at Roche/Genentech's new $2B greenfield start-up facility in Holly Springs, North Carolina. This facility, launching in 2028, is designed to be a global standard for high-volume, highly-efficient Drug Product manufacturing, leveraging advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes. It will produce CVRM (Cardiovascular, Renal, and Metabolism) medicines, focusing on next-generation metabolic medicines for obesity and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with high accountability, offering a unique opportunity to launch a state-of-the-art facility and shape its culture. The role seeks a highly impactful Principal QA Specialist with extensive experience, a robust risk-based operational focus, and a strong compliance mindset. This critical position ensures the delivery of top-quality products, meeting global regulatory requirements and Roche's internal standards. As a member of the QA team, the specialist will provide quality oversight for manufacturing and supporting processes, specifically for Compounding, Filling, and Inspection, managing end-to-end quality in these areas. Collaboration with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams, is essential to ensure strict adherence to quality standards. This role is key to embedding quality into the site's operational design, supporting a continuous improvement culture, and driving operational excellence in accordance with Good Manufacturing Practices, aiming to establish Holly Springs as a center of excellence for aseptic drug product manufacturing.

Requirements

Possess a Bachelor’s degree in a scientific discipline.
Minimum of 8–10 years in a GxP environment, with at least 4 years of sterile drug product manufacturing experience or Device assembly and packaging experience in either a manufacturing, QA Operations or MSAT role.
Be a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution, delivering operationally implementable solutions.
Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
Expertise in Quality Assurance, demonstrated by successful oversight of critical quality systems, including deviation management, CAPA, and product release processes.
Experience leading complex investigations and strong technical writing skills.
Excel at 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 operationally comply with these regulatory requirements.
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 and fast-paced environment while always ensuring the highest quality and safety standards.

Nice To Haves

A graduate or higher-level degree.

Responsibilities

Support the establishment and implementation of operational procedures for Compounding, Filling and Inspection or Assembly and Packaging, ensuring appropriate risk-based controls are in place to embed “Quality by Design” into operational processes.
Approve procedures and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
Work closely with the MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
Design the logic for Release by Exception, defining which critical process parameters must be automatically verified to allow for accelerated batch disposition.
Support equipment and process design reviews, FAT, SAT and commissioning activities to design fit for purpose, lean, operational processes in advance of PQ.
Support or lead complex investigations, determining root causes and ensuring the implementation of effective Corrective and Preventive Actions. Utilize advanced tools to move beyond "human error" and identify true systemic vulnerabilities. Approve Deviations and CAPAs.
Act as a subject matter expert and provide guidance on matters related to Compounding, Filling and Inspection or Assembly and Packaging, monitoring data and trends and identifying areas for improvement.
Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections.
Participate in equipment and process risk assessments, approve change controls and perform release of incoming goods and manufactured products.
Provide direct oversight of dispensing, compounding, filling, visual inspection and process support operations, including oversight of cleanroom processes and behaviors, sterilization cycles and validation activities.
Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization and validation activities.
Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes, replacing traditional paper documentation.