Senior QA Specialist, CVRM

Genentech; Holly Springs (MS); On-site; USD 120,000 - 160,000; Full time

Job summary

Genentech in Holly Springs, NC seeks a Senior QA Specialist to ensure delivery of high-quality products and regulatory compliance in a fast-paced, launch-ready facility. You will oversee manufacturing processes, deviations, and change controls with a focus on ALCOA+ data and robust investigations.

The role emphasizes end-to-end product release, sample management, and cross-functional QA support across MSAT, IT/OT, Supply Chain, and Facilities/Engineering to sustain operational excellence.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 6-8 years in a GxP environment with 3+ years in QA Operations or Manufacturing.
• Experience in sterile drug product manufacturing or device assembly.
• Proven ability to lead deviations, CAPA, and regulatory investigations.

Responsibilities

• Oversee manufacturing processes and ensure quality compliance.
• Lead investigations, deviations, CAPA, and root cause analysis.
• Support change control, risk assessments, and continuous improvement.
• Release of products and incoming goods with QA sign-off.
• Prepare for inspections and support regulatory dossiers.

Skills

QA oversight

GxP compliance

Root cause analysis

Deviations management

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree preferred

Tools

SAP

MES

Job description

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.

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, including MSAT, IT/OT, Supply Chain, and Facilities/Engineering.

Who You Are

• Bachelor's degree in a scientific or engineering discipline (a Master's or advanced degree is strongly preferred).
• Minimum of 6-8 years of experience in a GxP environment, with at least 3 years in an operational role within QA Operations, Manufacturing, or MSAT, specifically supporting sterile drug product manufacturing or device assembly.
• Proven expertise in Quality Assurance oversight, including direct responsibility for major deviations, root cause analysis, complex investigations, CAPA effectiveness, and final batch disposition/product release.
• In-depth understanding of global regulatory standards, including EU Annex 1 and FDA/EMA regulations, with demonstrated experience participating in global regulatory inspections.
• Practical experience with GxP digital tools and automated systems (e.g., SAP, MES), with the ability to translate business processes into compliant digital workflows and enforce ALCOA+ data.