Senior QA Specialist, CVRM

Roche • Holly Springs, NC

9h • $94,000 - $174,600 • Onsite

About The Position

Genentech is hiring two Senior QA Specialists for its Holly Springs, North Carolina facility, a new $2 billion drug product manufacturing site planned to launch in 2028. The facility will manufacture cardiovascular, renal, and metabolism (CVRM) medicines, including next-generation metabolic medicines for obesity and Type 2 diabetes, using advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes.

The Senior QA Specialist provides risk-based quality assurance oversight for manufacturing, warehouse operations, and support functions. The role works closely with cross-functional partners to ensure compliance with global regulatory requirements, Good Manufacturing Practices, and Roche's internal standards. It will help embed quality into site operations, support continuous improvement, and promote operational excellence in aseptic drug product manufacturing.

The role includes oversight of manufacturing processes and quality systems; leadership and review of investigations, deviations, and CAPAs; review and approval of change controls and procedures; release and disposition activities; and support for regulatory inspections. The expected salary range for the primary location is $94,000–$174,600. A discretionary annual bonus may be available based on individual and company performance. Relocation assistance is not available.

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 direct 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, and experience participating in global regulatory inspections.
• Practical experience with GxP digital tools and automated systems, such as SAP and MES, and ability to translate business processes into compliant digital workflows and enforce ALCOA+ data integrity principles.
• Strong Quality Risk Management (QRM) and Operational Excellence mindset, with experience driving continuous improvement and embedding lean quality practices in high-volume manufacturing.
• Strategic systems-thinking ability, excellent technical writing skills, and a collaborative approach to cross-functional problem-solving in a fast-paced environment.

Nice To Haves

• A Master’s or advanced degree is strongly preferred.

Responsibilities

• Provide 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 deviation investigations and ensure they are thorough and robustly documented.
• Participate in equipment and process risk assessments; review and approve operational change controls, process parameter optimizations, minor equipment adjustments, and continuous improvement projects.
• Perform incoming goods, intermediate product, and finished product release, and review manufacturing activities.
• Conduct quality evaluations, release holds, and final disposition reviews for outgoing drug product shipments.
• Approve site procedures and regularly evaluate and refine processes and standard operating procedures to drive 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 support functions, including MSAT, IT/OT, Supply Chain, and Facilities/Engineering.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits detailed at a link in the posting; specific benefits are not listed.

What This Job Offers

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