Head of Site Quality

The Company is seeking a Head of Site Quality to lead the quality and regulatory function for a sterile pharmaceutical and medical device manufacturing site. This pivotal role is not focused on maintenance but on driving transformation and long-term performance. The successful candidate will be responsible for rebuilding and strengthening core quality systems, improving inspection readiness, and establishing a more effective and scalable operating model. The Head of Quality will also oversee all aspects of site compliance, including cGMP, ISO, and global regulatory requirements, and will be the primary point of contact for inspections and regulatory agencies. Key responsibilities for the Head of Site Quality include leading large-scale quality initiatives, redesigning CAPA processes, and strengthening change control systems. The role demands a leader with a strong track record in quality system transformations, supporting FDA inspections, and managing complex regulatory environments. Candidates for this position should have significant experience in quality leadership within sterile manufacturing environments, with a focus on aseptic or terminal processes. Deep knowledge of cGMP standards, aseptic/terminal processing, and validation programs is essential, as is a proven ability to build teams, lead change, and drive measurable improvements in quality and compliance performance. The Head of Quality will also be instrumental in building and leading the site quality organization and establishing governance structures to ensure a strong quality culture.