Senior QA Specialist, QA for QC (CVRM)

Genentech•Holly Springs, NC

5d•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 As the QA Specialist (QA for QC), you will serve as a foundational pioneer embedding quality compliance directly into our Quality Control laboratory operations. You will be responsible for providing quality oversight to ensure the analytical, microbiological, and operational data generated within our state-of-the-art labs meets the highest global regulatory standards. In this role you will be a member of the QA team providing quality oversight for Quality Control. You will partner directly with the QC department to provide day-to-day quality compliance support, serving as a trusted gatekeeper for data integrity, support investigations and manage change controls related to laboratory systems, test methods, and digital applications, ensuring modifications do not compromise the validated state of our operations. 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

Bachelor’s degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
Minimum of 6–8 years in a GxP environment, with at least 4 years of broad QC experience, and clear operational exposure to quality compliance activities.
Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
Experience of the core QMS processes that support QC activities, including deviation management, CAPA, and change control.
Rigorous quality compliance mindset, with a strong understanding of the application of data integrity principles in Quality Control processes and equipment.
Experience leading complex investigations and strong technical writing skills.
Ability to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

Nice To Haves

You excel at embedding operational excellence in QC activities.
You have experience implementing and driving a continuous improvement culture.

Responsibilities

Support the establishment and implementation of operational procedures for Quality Control activities, ensuring appropriate risk-based controls are in place to embed “Quality by Design” into QC processes.
Approve procedures, specifications and methods, release materials and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
Support commissioning and qualification activities to design fit for purpose, lean, operational processes in advance of process PQ.
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.
Act as a subject matter expert and provide guidance on matters related to Quality Control activities, monitoring data and trends and identifying areas for improvement.
Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections.
Participate in equipment and process risk assessments, approve change controls, participate in daily triage and quality event working sessions. Perform periodic audit trail reviews, lab self inspections and Gemba walks.
Provide direct oversight of Quality Control activities, including Sampling Plans, Environmental & Utility trend reports, APR data verification, Stability Protocols & reports, and approve method transfer plans and reports.
Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of QC activities, replacing traditional paper documentation.