347986BR
Aug 11, 2022
Italy

Job Description

Over 1000 associates at 31 sites in 12 countries currently make up Advanced Accelerator Applications. AAA is also an expanding business where we have the unique advantage to leverage the size and scale of Novartis, while working in a culture that is unbossed, curious and inspired – all to create impact for patients.

The Site Quality Head leads the Site Quality function to ensure that all aspects of the operational business across the site comply with the cGMPs, Legal and Regulatory requirements and the AAA quality management system as per GMP regulation and corporate guidelines and to ensure that the proper quality organization in the site is in place.
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Your key responsibilities:

Your responsibilities include, but are not limited to:
• 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.
• Guarantee the update status, the correct registration and archiving of the documentation at local level.
• 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.
• Approval at local level of OOS, Deviations, Change Control, preparation of the annual training and self-inspection plan.
• Provide inputs for the selection, training, people development and performance evaluation, development planning in recruiting process of QA and QC Managers in the site.


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• At least 5 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
• Knowledge of quality system (ISO and GMP).
• Basic knowledge of regulatory requirements.
• Fluent in English.


Work location: Meldola (Forli’).

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), 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!

Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Italy
Meldola
Quality
Full Time
Regular
No
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347986BR

Site Quality Head

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