Director, Quality Systems

Position: Director, Quality Systems Responsibilities Provide governance and oversight of the Quality Management System (QMS) to ensure sustained compliance with applicable GxP regulations. Monitor evolving global regulatory requirements and proactively update quality systems and procedures to maintain continuous compliance. Lead lifecycle management, configuration, and continuous improvement of electronic quality systems (EDMS, LMS, and related GxP platforms). Serve as system owner for Veeva Vault Quality (user management, system configuration, document workflows, reporting). Lead and support validation activities for GxP computerized systems (Computer System Validation (CSV) and Computer Software Assurance (CSA)). Ensure all GxP systems remain validated throughout their lifecycle (change management and periodic review). Ensure compliance with 21 CFR Part 11 and applicable electronic records/signature requirements. Own and continuously improve document control (authoring, review, approval, distribution, archiving). Lead administration and optimization of the learning management system (curricula, role-based training, compliance tracking). Develop, monitor, analyze, and report quality system metrics; support management review. Conduct internal audits and ensure timely investigation/resolution of gaps or nonconformances. Identify and drive continuous improvement initiatives to enhance efficiency, scalability, and compliance. Support inspections and audits (regulatory authority and partner audits). Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed. Perform additional duties as assigned. Required Bachelor’s degree in a related scientific or technical discipline. 10+ years’ industry experience supporting GxP quality systems (biologics, pharmaceuticals, medical devices, or combination products). Strong electronic document management system knowledge; Veeva Vault Quality experience preferred. Expertise in CSV, CSA, and GxP computerized system lifecycle management. In-depth knowledge of FDA, ICH, and global GxP regulations, including 21 CFR Part 11. Strong problem-solving, organizational, and communication skills. Ability to work independently and collaborate cross-functionally in a fast-paced environment. High attention to detail and adaptability; continuous improvement mindset. Location Brisbane, California; preference for San Francisco Bay Area. Benefits Flexible work schedules, remote opportunities, shuttle service, competitive base salary/equity, employee stock purchase plan, and comprehensive health benefits including 401(k) and flexible spending plans. #J-18808-Ljbffr Scorpion Therapeutics