Senior QA Specialist, CVRM
About The Position
Two Senior QA Specialist positions are available at Genentech’s Holly Springs, North Carolina facility, a new $2 billion greenfield site for high-volume drug product manufacturing. The plant is designed around advanced automation, robotics, digital tools, real-time data analytics, and streamlined processes. It will manufacture CVRM (Cardiovascular, Renal, and Metabolism) medicines, with a planned launch in 2028. The Senior QA Specialist provides risk-based Quality Assurance oversight for manufacturing, warehouse operations, and support functions. The role helps ensure product quality and compliance with global regulatory requirements and company standards. It also offers the opportunity to embed quality into site operations, support continuous improvement, and advance operational excellence in accordance with Good Manufacturing Practices. The position works closely with cross-functional partners and provides oversight across manufacturing and warehouse activities, quality investigations and change controls, product release, quality systems, inspection readiness, and support-function operations.
Requirements
- Bachelor’s degree in a scientific or engineering discipline.
- At least 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 demonstrated 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.
- 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 collaborative cross-functional problem-solving skills in a fast-paced environment.
Nice To Haves
- A 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, including 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; and 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 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 benefits detailed at the link provided in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
