Senior Quality Compliance Specialist, CVRM (Holly Springs)

Position Overview Senior Quality Compliance Specialist – responsible for designing and implementing site‑wide Quality Risk Management, Data Integrity, and Change Control initiatives, ensuring compliance with global regulations and Roche internal standards. What You’ll Do Quality Risk Management (QRM) Serve as the premier site expert in QRM, facilitating complex risk assessments and translating risk‑based data into sustainable operational controls. Apply advanced proficiency in QRM methodologies (e.g., FMEA, PHA) to complex operational challenges. Lead or support risk assessments and change control activities, particularly for high‑impact processes. Own the site risk register and lifecycle management of risk assessments. Data Integrity Take full ownership of the site Data Integrity program, ensuring 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 it into the site ramp‑up strategy. Change Control Serve as site subject‑matter expert for change control. Chair the site Change Review Board, evaluating, challenging, and approving high‑impact modifications during commissioning, validation, and commercial phases. Drive consistent execution of the change control program. Core Quality Compliance Support Partner cross‑functionally to drive a proactive, risk‑based quality culture, providing technical and organizational leadership toward resolving compliance issues. Provide oversight of core quality systems, ensuring consistent compliance, operational effectiveness, and continuous improvement. Support compliance processes including Quality Escalations, Product Recalls, Inspection Management, Self-Inspection, the Site Master File, Management Review, Supplier Management, Metrics & Reporting, and Health Authority engagement. Serve as subject‑matter expert on global regulated requirements and inspectional commitments, assessing compliance state and participating in action plans to correct deficiencies. Act as the site contact to engage with global stakeholders regarding compliance trends, knowledge sharing, and improvement initiatives. Who You Are 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 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. Experience translating QRM methodologies into operational controls for drug and combination products. 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. Ability to work in a dynamic and fast‑paced environment while ensuring the highest quality and safety standards. Relocation assistance is not available for this role. Salary & Benefits Estimated salary range: $94,000 – $174,600 (determined by experience, qualifications, geographic location, and other factors). Discretionary annual bonus may be available based on individual and company performance. The position qualifies for the benefits detailed at the provided link. Equal Opportunity Employer Genentech is an equal‑opportunity employer. It is the company’s policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form. #J-18808-Ljbffr F. Hoffmann-La Roche AG