Principal QA Specialist (Multi-dose pens), CVRM

Genentech; Holly Springs (MS); On-site; USD 130,000 - 180,000; Full time

Job summary

Genentech's Holly Springs facility seeks a Principal QA Specialist to drive quality oversight for cartridge filling, inspections, assembly and packaging. You will partner with MSAT, Operations, Engineering, Quality, QC and Global teams to ensure compliance with GMP and regulatory standards.

You will embed Quality by Design into operational processes and support continuous improvement, risk-based controls, and inspection readiness to position Holly Springs as a center of excellence for aseptic

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 8–10 years in a GxP environment with cartridge sterile drug product manufacturing exposure.

Responsibilities

• Quality by Design: establish and implement procedures embedding QbD into processes.
• Quality Management: approve procedures and drive continuous improvement.
• Digital Quality: align MES/SAP data with validated process parameters.
• Release by Exception: define parameters for accelerated batch disposition.
• Design & Commissioning: support FAT/SAT and PQ readiness for new equipment/processes.
• Investigations & CAPAs: lead root cause analyses and implement corrective actions.

Skills

Quality by Design

GxP experience

QA Oversight

Process Improvement

Regulatory Compliance

Education

Bachelor's degree in a scientific discipline

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 impactful Principal QA Specialist with 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 cartridge filling, inspections, assembly and packaging. 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 cartridge filling through packaging, 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 Filling, Inspection, Assembly, Packaging, and clean utilities, 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, and act as local Quality Product Owner.
• Manufacturing Process Oversight: Provide direct oversight of filling, visual inspection, device assembly and packaging and clean utility generation & distribution, including oversight of cleanroom processes and behaviors, sterilization cycles, labelling, serialization and validation activities.
• 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 cartridge sterile drug product manufacturing experience in either a manufacturing, QA Operations or MSAT role.
• You are a strategic a