Principal QMS Specialist, CVRM (Holly Springs)

Genentech•Holly Springs, NC

11d•Onsite

About 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 QMS Specialist who will take strategic ownership of the end-to-end design and execution of the local Quality Management System (QMS). This role is essential for providing a lean, efficient QMS framework 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 QMS team and will build a robust documentation framework from the ground up, ensuring seamless integration with Roche global standards. You will develop the monitoring processes to ensure the health and effectiveness of the local QMS, while utilizing data-driven insights to facilitate strategic decision-making and ongoing process optimization. You will collaborate closely with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global QMS teams, to create a robust, user centric local QMS. This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.

Requirements

Bachelor's degree in a scientific/technical discipline (Advanced degree preferred).
Minimum of 8–10 years in a GxP environment, with at least 4 years specializing in QMS design, implementation and governance
Experience in building a QMS in a greenfield/start-up manufacturing environment, or redesign of a Quality Management System preferred.
Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape.
Experience in managing both Device and Pharmaceutical QMS’s highly preferred.
Proven track record of collaborating with global partners to adopt fit for purpose procedures, identifying where site specific additions are required and when local only procedures are required, to create a lean, efficient, local QMS.
Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the Quality management System, it’s lifecycle and governance models with confidence and credibility.
Strong working knowledge of eDMS/eQMS systems. Veeva experience preferred.
Strong cross-functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution-oriented dialogue.
Strong problem-solving, organizational, and communication skills.
Ability to work independently while effectively collaborating in a cross-functional, fast-paced environment.
High attention to detail with the agility to adapt to changing priorities.
Continuous improvement mindset and comfort operating in a growing clinical-stage organization.
You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

Responsibilities

Assume ownership for the end-to-end design and execution of the local Quality Management System at the Holly Springs greenfield facility.
Ensure the site-level QMS remains fully integrated with Roche global standards and procedures while adhering to all applicable international regulatory requirements.
Develop the site's comprehensive documentation hierarchy and record management policies by utilizing global Roche/Genentech standards and drafting required local procedures to outline site-specific operations.
Deliver leadership and strategic oversight for the QMS to maintain continuous alignment with all relevant GxP regulatory requirements.
Direct support for regulatory filings, product launches, and global health authority inspections while maintaining a constant state of audit readiness.
Govern the Holly Springs QMS by monitoring process health and ensuring consistent execution across the facility.
Create and implement a robust framework for assessing and measuring the ongoing performance and health of site-specific QMS processes.
Establish effectiveness and efficiency KPIs to monitor QMS health, utilizing data-driven insights to facilitate strategic decision-making and ongoing process optimization.
Establish and govern local QMS, including procedures and work instructions to ensure compliance and operational efficiency.
Drive simplification, consistency and adoption of best practices.
Design and maintain compliant and usable document structures/templates, serve as the local owner for document lifecycle management, and partner with functional leaders to ensure timely document review and approval.
Act as the primary quality interface between global QMS teams and local site operations to facilitate seamless integration and ensure operational readiness.
Provide direct oversight and management of an external technical writing contract company to ensure the timely and compliant build-out of the local procedures.
Align with the Site Training Lead to develop a best in class digital training strategy for locally created procedures.
Serve as Local System Owner for eDMS/eQMS, providing user training, troubleshooting, and reporting.
Partner with global teams on system enhancements.