Director Quality Function

Role: Director of Quality Compliance at a biopharmaceutical site, responsible for leading compliance strategies, Quality Management System (QMS) governance, and inspection readiness programs. Key responsibilities include managing external audits, overseeing supplier qualification, leading Nitrosamines risk management, and fostering a culture of quality and data integrity. The role utilizes advanced data analytics, predictive risk monitoring, and digital quality platforms to proactively identify and mitigate compliance risks, ensuring regulatory adherence and operational excellence. Responsibilities extend to coordinating regulatory inspections, managing CAPA programs, and leading cross-functional teams for continuous improvement. Requirements: Bachelor's in Science, Engineering, or related field; minimum 10 years’ pharmaceutical industry experience with at least 6 in a managerial role. Skills include expertise in QMS implementation, risk modeling, trend analysis, and effective communication with senior management. Preferred qualifications encompass experience with cGMPs, regulatory audits, and familiarity with AI and data analytics tools. The role involves strategic collaboration with Quality, Manufacturing, Regulatory, Supply Chain, and IT teams. The position is based at a biopharma site, with responsibilities spanning regulatory compliance, inspection readiness, and digital platform oversight.