Senior Quality Compliance Specialist, CVRM (Holly Springs)

About the role

Roche/Genentech is building a new $2B greenfield facility in Holly Springs, North Carolina, dedicated to manufacturing cardiovascular, renal and metabolism (CVRM) medicines, with a planned launch in 2028. The company is looking for a Senior Quality Compliance Specialist with broad experience and a strong risk-based, compliance-focused approach. As a key member of the Quality Compliance team, you will own the site's Quality Risk Management and Data Integrity initiatives and work with Engineering, MSAT, Warehouse, Operations, Quality, QC and global organizations.

Key responsibilities

• Lead or support risk assessments and change control, especially for high-impact processes, and maintain the site risk register
• Own the site Data Integrity program, including deep-dive assessments and the cultural program, and integrate risk-based controls into recipes, analytical methods and procedures
• Serve as site subject matter expert for change control and chair the site Change Review Board
• Support compliance processes such as Quality Escalations, Product Recalls, Inspection Management, Self-inspection, the Site Master File, Management Review, Supplier Management, Metrics and Reporting, and Health Authority engagement
• Act as the site contact for global stakeholders on compliance trends and improvement initiatives

Required profile

• Bachelor's degree in a scientific or technical discipline (advanced degree preferred)
• At least 8-10 years in a GxP environment, with at least 4 years leading QRM, Data Integrity or Change Control programs at a manufacturing site
• Experience developing, implementing or auditing site-wide Data Integrity programs in highly automated facilities
• Extensive experience with regulatory inspections and health authority interactions
• Broad experience across Quality and/or operations preferred

Required skills

• Knowledge of FDA, EMA, ICH and ISO regulations
• Proficiency in QRM methodologies such as FMEA and PHA
• Ability to translate QRM into operational controls for sterile drug products

What we offer

• Expected salary range of $94,000 - $174,600, depending on experience and qualifications
• A discretionary annual bonus may be available
• Relocation assistance is available