.AAA StatementAdvanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE). About the roleLocation: Salamanca.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 siteGuarantee the compliance of the local quality system to the GMPs and corporate guidelines; Define, approveand 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 locallevel 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.Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role RequirementsObligatory requirements:Education: Degree in PharmacyAt least 3 years of experience in a pharmaceutical quality department (QA or QC)Excellent organizational skills (time management, risk management) including attention to detail and multitasking skillsSolid Knowledge of quality system (ISO and GMP)Strong Leadership skillsReliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system.Fluent English and Spanish, other languages are a plusThe Site Quality Head will be actively involved in the start-up of the new facility of Salamanca which construction is about to start
