Senior QA Specialist, CVRM

Genentech; Holly Springs (AL); Vor Ort; USD 94.000 - 175.000; Vollzeit

Zusammenfassung

Genentech, Inc. in Holly Springs, NC, is building a state-of-the-art, high-volume drug product facility with a strong emphasis on quality, compliance, and operational excellence.

We are seeking a Senior QA Specialist to lead QA oversight of manufacturing and warehouse activities, drive deviations investigations, CAPAs, and support inspections while embedding ALCOA+ data integrity and continuous improvement into daily operations.

Qualifikationen

• Requires strong QA oversight in a GxP environment.
• Experience in major deviations, CAPA, investigations, and batch disposition.
• Knowledge of global regulatory standards and inspections.
• Proficiency with digital tools and automated systems for compliant workflows.

Aufgaben

• Oversee manufacturing and warehouse QA activities with risk-based focus.
• Lead investigations, deviations, CAPAs, and ensure effective corrective actions.
• Participate in change controls, risk assessments, and process improvements.
• Perform incoming goods and final product release activities with QA sign-off.
• Support regulatory inspections and dossier review for quality sections.
• Provide QA guidance to MSAT, IT/OT, Supply Chain, and Facilities/Engineering.

Kenntnisse

QA Oversight

GxP Compliance

Regulatory Inspections

Change Control

Data Integrity

Ausbildung

Bachelor's degree in science/engineering

Master's degree preferred

Tools

SAP

MES

Jobbeschreibung

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, 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 integrity principles.
• Strong mindset for Quality Risk Management (QRM) and Operational Excellence, with experience driving continuous improvement and embedding lean quality practices in high-volume manufacturing.
• Strategic, systems thinker with excellent technical writing skills and a collaborative approach to cross-functional problem-solving in a fast-paced environment.

Relocation Assistance is not available for this role.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $94,000 - $174,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.