392181BR
Feb 14, 2024
Spain
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.
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:
Join our Novartis Network.
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
- 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:
Join our Novartis Network.
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Oncology
Molecular Imaging
Spain
Salamanca
AAA Ibérica S.L.U.
Quality
Full Time
Regular
No
