May 18, 2023

Job Description

The Site Data Integrity Manager leads the implementation of site actions according to the Data Integrity (DI) Plan. Be an ambassador for DI driving awareness and change management activities necessary for a culture of DI excellence, including mitigation of risks associated with lack of such culture and awareness, and supporting with assuring appropriate systems and processes are in place to support GxP data integrity.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Drive, monitor and assure delivery of the DI Plan site actions, supporting behavioral change management to strengthen the DI culture and reporting status / progress to the Site Quality Head, and Regional DI lead as required.
• Collaborate with site DI Champions and DI SPOCs (if applicable) on their local departments DI actions and related DI challenges and issues to drive behavioral change management activities to strengthen DI culture.
• Perform regular DI walkthroughs with DI Champions in the GxP areas including QC, Production, Packaging, and control room.
• Active member of the DI Community, serving as a site representative and subject matter expert for DI-related inquiries / trainings. Specifically, establishing and leading the country network across GxP functional areas, supporting with DI topics in investigations and collaborating and sharing best practices / lessons learnt with the DI Community.
• Conduct frequent informal small group discussions within relevant area or department.to promote discussion/engagement and focus on the factors impacting the decision-making process.
• Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus on the existing process. (e.g. DI walkthroughs and Small Group Discussions).
• Drive and support DI escalation and investigation process for DI issues at the site.
• Oversee implementation of corrective and preventive measures (CAPA).
• In the event of DI breaches ensure that associates are aware of the events and recognize the importance of such compliance issues.
• Sharing lessons learned from DI escalations, Health Authority observations during DI and Good Documentation Practice discussions.

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:

• Scientific or IT Degree.
• At least 5 years of cross-functional experience in GxP regulated environment, in Quality / Manufacturing/ Engineering departments.
• Experience in working in a diverse, matrix environment, with ability to drive and manage change across different cultures.
• Excellent organizational (time management, risk management) and communication skills.
• Fluent in Italian and English.

Work location: Colleretto Giacosa (Ivrea).

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!

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
careers default image

Site Data Integrity Manager

Apply to Job Access Job Account