The Biotech Job Board
Built by Scientists
for Scientists

Where Science Careers Launch

Site Quality Head - Esplugues



Quality Assurance
Posted on Friday, May 26, 2023
365 days a year, our global manufacturing and supply network works to ensure our patients have the treatments they need to live longer, healthier lives.

Work location: Esplugues (Barcelona)

Job Purpose:
The Site Quality Head is responsible to ensure that all aspects of the operational business across the sites comply with the cGMP, Legal and Regulatory requirements and the Advanced Accelerator Applications quality management system as per GMP regulation and corporate guidelines. The SQH coordinates at local level the implementation, follow up and completeness of all related Quality programs, documentation and Quality reporting and ensures that the proper quality organization in the country is in place.

Major accountabilities:
• Provide the strategic and technical leadership for site
• Guarantee the compliance of the local quality system to the GMPs and corporate guidelines;
• Define, approve and guarantee the application of all the site quality system procedures;
Monitor the execution of maintenance, qualification, calibration and revalidation programs at local level;
• Coordinate the quality assurance manager and the quality control manager through the application of the GMP and the guidelines of the Quality Country Head and the Quality head office;
• Actively participate to the audits performed at the site by the Quality Country Head;
• Manage at local level the follow up of the Health Authorities and the subcontractor inspections;
• Collaborate with the Quality Country Head to the execution of audits and qualification of suppliers.