SITE QUALITY HEAD

About the Role Location.
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 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.
Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements 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 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.
Why Advanced Accelerator Applications? Thousands of people die of cancer around the world every day.
At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer.
How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.
Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion.
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