Sr. Mgr., Quality Management Systems

Role: Senior Manager, Quality Management Systems, overseeing the company's QRM program and supporting GxP compliance. Responsibilities: lead development and continuous improvement of QRM procedures, facilitate cross-functional risk assessments using methodologies like FMEA, and ensure risk mitigation actions are tracked and addressed; serve as backup for Document Control and GxP Training; maintain inspection-ready documentation, support audit preparations, and collaborate across GMP, Clinical, CMC, and Regulatory functions. Support digital quality systems and risk-based validation of GxP computerized systems. Requirements: Bachelor's degree in a scientific or technical field; 7+ years’ experience in Quality Assurance within biotech/pharma; proven expertise in building and deploying QRM programs in GxP environments; working knowledge of GxP regulations and global expectations; hands-on experience with Veeva Vault Quality applications; familiarity with computer system validation and risk-based lifecycle approaches. Preferred: experience with APQR/PQR activities, QRM metrics, and management review reporting. HighValue: focus on GxP compliance, risk management, inspection readiness, and digital quality systems in a biotech setting. Work setup: remote US-based role with periodic travel to San Francisco.