Senior QA Specialist, CVRM

Genentech • Holly Springs, NC

1d • Onsite

About The Position

Genentech is hiring two Senior QA Specialists for its Holly Springs, North Carolina facility, a $2B greenfield site planned to launch in 2028. The facility will manufacture Cardiovascular, Renal, and Metabolism (CVRM) medicines, including next-generation metabolic medicines, using advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes. The role is part of a fast-paced, accountable environment focused on high-volume drug product manufacturing and operational excellence.

The Senior QA Specialist is a member of the QA team and provides quality oversight for manufacturing, warehouse operations, and support functions. The role helps ensure products meet global regulatory requirements and Roche's internal standards while embedding quality into site operations, supporting continuous improvement, and promoting Good Manufacturing Practices. The specialist works closely with cross-functional partners and supports the development of Holly Springs as a center of excellence for aseptic drug product manufacturing.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• 6–8 years of experience in a GxP environment, including at least 3 years in an operational role within QA Operations, Manufacturing, or MSAT supporting sterile drug product manufacturing or device assembly.
• Demonstrated QA oversight expertise, including responsibility for major deviations, root cause analysis, complex investigations, CAPA effectiveness, and final batch disposition or product release.
• In-depth understanding of global regulatory standards, including EU Annex 1 and FDA/EMA regulations.
• Experience participating in global regulatory inspections.
• Practical experience with GxP digital tools and automated systems, such as SAP and MES.
• Ability to translate business processes into compliant digital workflows and enforce ALCOA+ data integrity principles.
• Quality Risk Management and Operational Excellence mindset, with experience driving continuous improvement and embedding lean quality practices in high-volume manufacturing.
• Strategic, systems-thinking approach, excellent technical writing skills, and a collaborative approach to cross-functional problem-solving in a fast-paced environment.

Nice To Haves

• Master’s or advanced degree.

Responsibilities

• Provide direct QA oversight of compounding, filling, visual inspection, device assembly, packaging, clean utility generation and distribution, and warehouse activities.
• Oversee cleanroom behaviors, sterilization cycles, labeling, serialization, and validation operations.
• Serve as a QA center of excellence for major investigations, CAPAs, and effectiveness checks.
• Review and approve deviations; lead or support complex investigations, determine root causes, and ensure effective corrective and preventive actions are implemented.
• Coach teams on deviations and ensure investigations are thorough and well documented.
• Participate in equipment and process risk assessments; review and approve operational change controls.
• Approve process parameter optimizations, minor equipment adjustments, and continuous improvement projects.
• Perform incoming goods, intermediate product, and finished product release, and review manufacturing activities.
• Execute quality evaluations, release holds, and final disposition reviews for outgoing drug product shipments.
• Approve site procedures and evaluate and refine processes and standard operating procedures to improve operational efficiency.
• Support inspection readiness, participate in regulatory inspections, and support review and approval of dossier sections.
• Provide QA oversight for sample management, monitor operational metrics, and analyze quality data.
• Provide QA guidance to MSAT, IT/OT, Supply Chain, and Facilities/Engineering.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• Benefits are available as detailed at the link provided in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior