Principal QA Specialist (Multi-dose pens), CVRM

F. Hoffmann-La Roche AG; Holly Springs (MS); Presencial; USD 115.000 - 213.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation benefits

Descripción de la vacante

Roche/Genentech in Holly Springs, NC is building a state-of-the-art drug product facility. We seek a Principal QA Specialist with a strong compliance mindset to provide quality oversight for cartridge filling, inspections, assembly and packaging, ensuring GMP and regulatory requirements are met.

You will partner with MSAT, Operations, Engineering and Quality to embed Quality by Design, drive continuous improvement, and lead investigations and CAPAs.

Formación

• Bachelor's degree in a scientific discipline; PhD/advanced degree preferred.
• 8–10 years in a GxP environment with 4+ years in cartridge sterile drug product manufacturing (QA Operations/MSAT).
• Experience with regulatory inspections (FDA/EMA) and quality systems (deviations, CAPA, product release).
• Hands-on experience with SAP and MES; knowledge of Annex 1 compliance.

Responsabilidades

• Quality by Design: establish and implement operational procedures for cartridge filling to embed QbD into processes.
• Quality Management: approve procedures and drive continuous improvement for efficiency and effectiveness.
• Digital Quality: collaborate with MES and SAP teams to design recipes and Manufacturing Batch Records.
• Release by Exception: define critical parameters for automatic verification to accelerate batch disposition.
• Design & commissioning: support FAT, SAT and commissioning for lean, compliant processes.
• Investigations: lead complex investigations and implement effective CAPAs.
• Technical expert: advise on filling, inspection, assembly, packaging, and clean utilities.
• Inspection support: readiness and review of dossiers during regulatory inspections.
• Compliance: participate in risk assessments, approve change controls, act as Quality Product Owner.
• Manufacturing Oversight: oversee filling, inspection, assembly, packaging, clean utilities and related processes.
• Digital Footprint: QA Owner for digital shop-floor applications.

Conocimientos

Quality Assurance

GxP Compliance

Risk-based QA

CAPA & Deviations

Root Cause Investigation

Educación

Bachelor's degree in a scientific discipline

Herramientas

SAP

MES

Descripción del empleo

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 and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution, delivering operationally implementable solutions. Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA). You have expertise in Quality Assurance, demonstrated by your successful oversight of critical quality systems, including deviation management, CAPA, and product release processes. You have experience leading complex investigations and have strong technical writing skills. You excel at embedding operational excellence in complex, large-scale manufacturing environments. You have experience implementing and driving a continuous improvement culture. Good understanding of Annex 1 and how to operationally comply with these regulatory requirements. Hands-on experience with SAP and MES. You should be able to explain how a "Business Process" translates into a "Digital Recipe." You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

Relocation Benefits are available for this role.

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $114,700 - $212,900. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Link to 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.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.