Head of Site Quality

The Company is seeking a Head of Site Quality to lead and transform the quality and regulatory function at a sterile pharmaceutical and medical device manufacturing site. The role is responsible for site compliance with cGMP, ISO, and global regulatory requirements, and serves as the primary contact for inspections and regulatory agencies. Key duties include overseeing batch release, product disposition, regulatory submissions, and inspection readiness while ensuring quality systems support operational performance. The leader will strengthen CAPA and change control processes, advance aseptic and sterile manufacturing programs, build the site quality organization, and lead customer and regulatory audits. Candidates should have significant quality leadership experience in sterile manufacturing, including direct responsibility for site-level quality functions. A strong record of transforming quality systems, supporting regulatory inspections, and managing complex regulatory environments is required. The role calls for deep knowledge of cGMP standards, aseptic or terminal processing, and validation programs. Candidates should also demonstrate the ability to build teams, lead organizational change, and deliver measurable improvements in quality and compliance.