Principal QA Specialist (Manufacturing QA), CVRM

Roche•South San Francisco, CA

About The Position

Two Principal QA Specialist positions are available: one will focus on Compounding, Filling, and Inspection, and the other will support Packaging and Labelling. 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 Compounding, Filling, and Inspection. 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.

Requirements

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 sterile drug product manufacturing experience or Device assembly and packaging 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.

Responsibilities

Quality by Design: Support the establishment and implementation of operational procedures for Compounding, Filling and Inspection or Assembly and 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 Compounding, Filling and Inspection or 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 and Product Release: Participate in equipment and process risk assessments, approve change controls and perform release of incoming goods and manufactured products
Manufacturing Process Oversight (Compounding, Filling and Inspection): Provide direct oversight of dispensing, compounding, filling, visual inspection and process support operations, including oversight of cleanroom processes and behaviors, sterilization cycles and validation activities.
Manufacturing Process Oversight (Assembly and Packaging): Provide direct oversight of device assembly and packaging and process support operations, including 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.