Two Senior QA Specialist positions are available.
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant, you will build the future of medicine.
The Opportunity
We are looking for a highly impactful Senior QA Specialist with a robust risk-based operational focus and a strong compliance mindset. This critical role is essential for guaranteeing the delivery of top-quality products, consistently meeting global regulatory requirements and Roche's stringent internal standards.
In this role, you will be a member of the QA team providing Quality oversight for all manufacturing and warehouse operational activities. You will also provide QA oversight for support functions and directly collaborate closely with cross-functional partners to guarantee strict adherence to quality standards.
This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.
What You’ll Do
Manufacturing Process Oversight: Provide direct oversight of compounding, filling, visual inspection, device assembly, packaging, clean utility generation and distribution, and warehouse activities, including cleanroom behaviors, sterilization cycles, labeling, serialization, and validation operations.
Investigations & Deviations: Serve as the QA center of excellence for major investigations, CAPAs, and effectiveness checks. Act as Reviewer and Approver for deviations, leading or supporting complex investigations, determining root causes, and ensuring implementation of effective corrective and preventive actions. Act as a deviation coach and ensure investigations are thorough and robustly documented.
Compliance & Change Control: Participate in equipment and process risk assessments, review and approve operational change controls, approve process parameter optimizations, minor equipment adjustments, and continuous improvement projects.
Product Release & Incoming Goods: Perform incoming goods release, intermediate & finished product release, and review of all manufacturing activities. Execute quality evaluations, release holds, and final disposition reviews for outgoing drug product shipments.
Quality Management: Approve site procedures and drive operational efficiency by regularly evaluating and refining processes and standard operating procedures (SOPs).
Inspection Support: Support inspection readiness, participate during regulatory inspections, and support review/approval of dossier sections.
Cross-Functional QA Support: Provide QA oversight for sample management, monitor operational metrics, and analyze quality data. Extend QA guidance to support functions,…