Principal QA Specialist (Assembly & Packaging), CVRM

Genentech; Holly Springs (MS); On-site; USD 130,000 - 190,000; Full time

Job summary

Genentech is seeking a Principal QA Specialist in the Holly Springs area to provide quality oversight for Assembly, Packaging and Warehouse operations. You will collaborate with MSAT, Operations, QA, and Global teams to ensure adherence to GMP and regulatory standards.

The role emphasizes Quality by Design, continuous improvement, and digital transformation of shop-floor processes, with a focus on aseptic drug product manufacturing excellence.

Qualifications

• Bachelor's degree in a scientific field is required.
• 8–10 years in a GxP environment with 4+ years in device assembly/packaging.
• Experience with pre-filled syringes or autoinjectors is preferred.

Responsibilities

• Quality by Design: establish and implement procedures for Assembly, Packaging and Warehouse with risk-based controls.
• Quality Management: review procedures and drive continuous improvement to maximize efficiency.
• Digital Quality: collaborate with MES and SAP to design recipes and batch records; align master data with validated parameters.
• Release by Exception: design logic to automatically verify critical process parameters for batch disposition.
• Design & commissioning: support equipment/process design reviews, FAT/SAT, and PQ readiness.
• Investigations: lead root-cause analysis and implement effective CAPAs.
• Technical Expert: advise on Assembly and Packaging; monitor data trends for improvements.
• Inspection support: participate in regulatory inspections and dossier reviews.
• Compliance: participate in risk assessments and change controls.
• Manufacturing Process Oversight: oversee device assembly/packaging, labeling, serialization, validation, and material movement.
• Digital Footprint: QA owner for applications enabling digital shop-floor processes.

Skills

Quality by Design

Quality Management

Digital Quality

Release by Exception

Regulatory readiness

Problem solving

Inspection readiness

Education

Bachelor's degree in a scientific discipline

Tools

MES

SAP

Job description

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 im pactful Principal QA Specialist wit h extensive experience, 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 manufacturing and supporting processes, specifically for Assembly, Packaging and Warehouse operations. You will manage end-to-end quality for these areas, collaborating closely with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams, to guarantee strict adherence to all 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

• Quality by Design: Support the establishment and implementation of operational procedures for Assembly, Packaging and Warehouse operations, ensuring appropriate risk-based controls are in place to embed 'Quality by Design' into operational processes.
• Quality Management: Approve procedures and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
• Digital Quality: Work closely with the MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
• Release by Exception: Design the logic for Release by Exception, defining which critical process parameters must be automatically verified to allow for accelerated batch disposition.
• Design & Commissioning Phase: Support equipment and process design reviews, FAT, SAT and commissioning activities to design fit for purpose, lean, operational processes in advance of PQ.
• Investigations: Support or lead complex investigations, determining root causes and ensuring the implementation of effective Corrective and Preventive Actions. Utilize advanced tools to move beyond 'human error' and identify true systemic vulnerabilities. Approve Deviations and CAPAs.
• Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to Assembly and Packaging, monitoring data and trends and identifying areas for improvement.
• Inspection support: Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections .
• Compliance: Participate in equipment and process risk assessments, approve change controls.
• Manufacturing Process Oversight: Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization and validation activities, as well as warehouse operations and material movement throughout the facility.
• Digital Footprint: Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes, replacing traditional paper documentation.

Who You Are

• You possess a Bachelor's degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
• Minimum of 8-10 years in a GxP environment, with at least 4 years of Device assembly and packaging experience in either a manufacturing, QA Operations or MSAT role. Experience with pre-filled syringes or autoinjectors preferred.
• You are a strategic and systems thinker with a compliance focus, anticipating techno