Job Description:
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 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 AAA quality management system as per GMP regulation and corporate guidelines. The SQH coordinates at the 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 the site
Guarantee the compliance of the local quality system to the GMPs and corporate guidelines
Monitor the execution of maintenance, qualification, calibration and revalidation programs at the local level
Actively participate in the audits performed at the site by the Quality Country Head
Manage at the local level the follow-up of the Health Authorities and the subcontractor inspections
Collaborate with the Quality Country Head in 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 Pharmacy
At 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 skills
Solid Knowledge of quality system (ISO and GMP)
Strong Leadership skills
Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
Fluent in English and Spanish, other languages are a plus
The 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 a growing multinational pharma company that develops a job with direct impact on cancer patients.
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