May 30, 2022

Job Description

The Manager Research Quality & Compliance is responsible for the management of quality
program applicable at the Ivrea site to the wide range of discovery science and scientific
research activities including, but not limited to, implementation of data integrity
governing practices for Laboratory Notebooks and human tissue use in research are-as. The
role will partner with internal and external groups to support the implementation and
continuous improvement of relevant practices, facilitate quality issue resolution and
provide appropriate quality support to meet business and regulatory requirements while
maintaining the highest scientific standards and promoting a culture of quality and
compliance. This role will be the local representative for all quality related matters and
will ensure continuous communication and alignment with the rest of Research, Pre-Clinical
and Lab QA. as well as with other GxP (GLP/GMP/GCP) parts of the organization
The Manager Research Quality & Compliance will provide quality oversight and support for
the Oncology-Radio Ligand Therapy (ONC-RLT) project teams and for the Oncology-RLT
discovery & pre-clinical projects/data submitted to health authorities.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Ensures timely closure by the business of the gaps identified during the recent on site flash NIBRIS assessment.
• Provide data integrity (DI) trainings/on-boarding of new associates in Ivrea and be the point of contact for DI related questions.
• Coordinate, as required interactions with local Has (including during inspections and audits). Be the Quality contact èpersone for non-GxP –related matters at the time of HA interactions.
• Support evaluation of existing Quality processes across Research in Ivrea and contrib-utes to the identification of potential new gaps (including via conducting local NIBRIS assessments). Promote a robust quality culture in Ivrea across Non-GxP research & Lab.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:

Ideal background:

• Education: Degree in Scientific Field - Ph.D. in a Scientific and/or Engineering subject area preferred and/or related equivalent experience with in-depth understanding of the RLTs.
• Languages: Fluency in English and in Italian

Experience / Professional requirements:

• 6+ years broad experience in a scientific/pharmaceutical industry. Experience in a Biomedical research as well as regulatory environments are considered a plus.
• Project Management

Work location: Colleretto Giacosa (TO)

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
Colleretto Giacosa
Full Time
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Research Quality & Compliance Manager

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