Director of Quality Science and Technology

This senior leadership role is responsible for setting the quality strategy across a regulated product portfolio and ensuring strong oversight of compliance, risk, and product lifecycle readiness. The position supports biological materials, reagents, and complex chemical products, with accountability for quality planning from early development through commercialization, post-market monitoring, and end-of-life management. The Director partners closely with functions such as product development, manufacturing, supply chain, regulatory affairs, client teams, quality operations, and technical groups. A major part of the role is to establish risk-based quality expectations, guide decision-making on product and process risks, and promote a prevention-focused quality culture. Key responsibilities include leading quality input for design and development activities, supporting process scale-up and technology transfer, and reviewing change controls to confirm appropriate impact assessments and validation plans. The role also helps maintain the quality management system in line with applicable regulatory and industry requirements. In addition, this leader monitors performance trends, complaint and nonconformance data, audit findings, and other quality signals to drive continuous improvement and strengthen compliance. The successful candidate will provide technical authority, influence across teams, and support robust governance for regulated products without direct line responsibility.