Principal QA Specialist (Assembly & Packaging), CVRM

Genentech; Holly Springs (NC); Sur place; USD 115 000 - 213 000; Plein temps

Avantages offerts par ce poste

Relocation benefits

Résumé du poste

Genentech in Holly Springs, NC seeks a Principal QA Specialist to lead quality oversight for Assembly, Packaging, and Warehouse operations. You will embed Quality by Design, support continuous improvement, and ensure compliance with GMP standards while coordinating with MSAT, Operations, and Global teams.

This role emphasizes دستگاه assembly/packaging, regulatory readiness for FDA/EMA, and a digital quality footprint with SAP and MES.

Qualifications

• Bachelor’s degree in a scientific discipline; graduate or higher-level degree strongly preferred.
• 8–10 years in a GxP environment, with at least 4 years in device assembly and packaging.
• Experience with FDA/EMA inspections and regulatory compliance.
• Strong quality systems knowledge including deviation management, CAPA, and product release processes.

Responsabilités

• Provide quality oversight for Assembly, Packaging and Warehouse operations ensuring risk-based controls and Quality by Design.
• Approve procedures and drive continuous improvement of processes to maximize efficiency and compliance.
• Collaborate with MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams to maintain quality standards.

Connaissances

Quality Assurance

GxP

Device Assembly

Packaging

SAP

MES

Regulatory Inspections

Formation

Bachelor's degree in a scientific discipline

Outils

SAP

MES

Description du poste

The Position

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 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 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.
• 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.

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.