Vice President, Quality Management Systems and Digital Compliance

Role: Vice President of Quality Management Systems, responsible for defining and executing enterprise-wide quality strategies to enable growth from clinical development through commercialization of cell and gene therapies, particularly in advanced therapy medicinal products. Responsibilities include leading quality system modernization, digital transformation via eQMS, establishing governance frameworks, ensuring regulatory compliance, inspection readiness, and integrating digital innovations such as AI/ML. The role emphasizes building a high-performing quality team, partnering cross-functionally with R&D, manufacturing, regulatory, and commercial teams, and managing enterprise risk. Key tasks involve overseeing critical quality processes, driving continuous improvement, and supporting regulatory inspections and submissions. Requirements: 15-20+ years in quality leadership within biotech or pharma, with extensive experience in cell/gene therapy, biologics, or pharmaceuticals. Proven expertise in global regulatory requirements (FDA, EMA, PMDA), digital transformation, data integrity, GxP compliance, and quality methodologies like Lean Six Sigma. Preferred skills include advanced knowledge of ICH guidelines, enterprise eQMS implementation, and emerging technologies such as AI/ML. Qualifications: BS/MS/PhD in science, engineering, pharmacy, or medicine. High-value specifics: focus on ATMPs, digital quality systems, regulatory inspections, and global compliance. Location: not specified; likely senior leadership role with an emphasis on strategic influence and cross-functional collaboration.