Senior Manager, QC Chemistry and Device Testing (CVRM

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 Holly Springs Quality Control Team is seeking an experienced and dynamic leader to establish and head our QC Chemistry and Device Testing team. In this critical role, you will build a highly effective and engaged organization capable of delivering safe, compliant, and efficient testing for our CVRM (Cardiovascular, Renal, and Metabolism) products manufactured at the Holly Springs site. Initially, you will focus on laboratory start-up activities—establishing core QC capabilities to support facility, utility, and process qualifications—before pivoting to routine commercial operations following site licensure.

You will champion a proactive quality culture built on psychological safety and transparent communication—empowering your team to speak up, simplify processes, and take personal accountability for owning quality. You will drive a proactive safety culture by fostering Behavior-Based Safety (BBS) principles and ensuring strict compliance with site safety processes and regulatory standards. You will foster a high-performing, engaged lab culture by practicing Lean Leadership, providing active coaching, and embedding continuous improvement into daily operations.

You will partner with the global network to harmonize QC standards and ensure seamless execution and compliance across site operations.

• You will establish key operational performance measures (KPIs) with a focus on Compliance, Right-First-Time (RFT) execution and continuous improvement to meet business objectives.
• You will author, review, and approve critical technical, scientific, and compliance documents (e.g., test methods, validation protocols, SOPs).
• You will own Quality Management System (QMS) records, including investigations, deviations, CAPAs, and change controls.
• You will participate in the identification, evaluation, and implementation of new technologies in alignment with business objectives or regulatory requirements.
• You will have responsibility for strategic projects to support execution of QC network strategy.
• You are experienced in presenting QC topics during regulatory inspections and maintaining a continuous state of audit readiness across QC operations.

• You hold a B.S. or M.S. degree (Science related discipline) with a minimum of 8 years of experience in pharmaceutical or biopharmaceutical manufacturing.
• This includes at least 3 years of direct experience in QC operations at a finished drug product commercial manufacturing site.
• You have extensive technical knowledge of analytical methods, laboratory instrumentation, and analytical method validation, qualification, and transfer within the pharmaceutical or biopharmaceutical industry.
• You have in-depth working knowledge of cGMP operations, ICH guidelines, and global Health Authority regulatory requirements (FDA, EMA, etc.).
• You have…