Site Quality Head

hace 4 días


Salamanca, España Novartis A tiempo completo

.Advanced 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.AAA 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).- 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. Job PurposeThe 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 AAA 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; Monitor the execution of maintenance, qualification, calibration and revalidation programs at local level; - 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.Commitment to Diversity & Inclusion :Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._Obligatory 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 .We offer a market-competitive base salary in line with your qualification, experience and individual proficiencies, learning & development options and worldwide career opportunities within agrowing multinational pharma company that develops a job withdirect impact on cancer patients


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