Hiring: Senior Quality Compliance Specialist, CVRM (Holly Springs) Company: Genentech Location: Holly Springs, NC Job Posted Time: 2026-09-16 16:45:11 Target Skills & Keywords : Assembly, Risk Management About the job Experience: •10 years in a GxP environment, with at least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. •At least 4 years of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. Required Skills: •This position is a unique opportunity to embed a robust, risk-oriented Quality Culture 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. •Quality Risk Management (QRM) •Serve as the premier site expert in QRM, actively facilitating complex risk assessments and translating risk-based data into sustainable operational controls. •Lead or support risk assessments and change control activities, particularly for high-impact processes. •Owner of the site risk register and lifecycle management of risk assessments. •Take full ownership of the site Data Integrity program, ensuring all automated, digital, and analytical systems comply with internal standards and global regulations. •Coordinate and lead targeted deep-dive assessments focusing on data integrity elements. Identify and assess risks, integrating risk-based controls into the operational design of recipes, analytical methods and associated procedures. •Establish the site data integrity cultural program and integrate into the site ramp up strategy. Qualifications: •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 of accumulated experience in leading QRM, Data Integrity or Change Control programs at a manufacturing site. •Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) and their practical application in a digital manufacturing landscape for sterile drug product manufacturing and device assembly and packaging. •Demonstrated success developing, implementing, or auditing site-wide Data Integrity compliance programs within highly automated/digital facility footprints. •Broad experience across Quality and/or operations preferred. •Extensive experience with regulatory inspections and health authority interactions. •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. •You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards. •Relocation Assistance is available for this role. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!