343946BR
Apr 28, 2022
Slovenia

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
• QA eCompliance accountable to the assigned sites to ensure computerized systems compliance with all applicable Novartis and GxP regulatory expectations.
• Ensures in coordination with the Service Centers and site SMEs that QA eCompliance support is planned for and available for computerized system validation activities such as IT application validation, Process Automation qualification/commissioning, Lab automation qualification, change control, deviation management, Periodic Reviews, etc. (demand management).
• Represents QA eCompliance in the assigned sites’ Quality LT.
• Single point of contact to the assigned sites for inspections/audits, incidents, GxP escalations, applicable SOP implementations.
• Advise strategic projects on validation strategies including novel approaches to quality assurance, as well as, acts as QA eCompliance oversight as a project SteerCo member.
• Monitor the compliance state of the assigned sites including risk mitigation activities and current risk situations for computerized systems. Provide regular report to site and QA management and escalates major issues as needed.
• Actively participate in strategic activities to promote Quality mindset, efficiencies, process improvements, etc.
• Regional expert to support and guide on GxP Computerized System topics.

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 will bring to the role:
• University education (e.g .: computer science, engineering, chemistry, pharmacy, biology) or FH with scientific / technological background.
• Fluency in English. German is a plus.
• 6-7 years of relevant experience in the Pharmaceutical Industry in regulated functions such as Quality, Compliance, IT Quality, GMP Production.
• Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
• Highly experienced in the development, implementation and lifecycle management of computerized systems in regulated environments.
• Highly experienced in the operational management of GxP solutions including its related technologies to support the operation.

You’ll receive

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Sports Club Membership, employment at Top SI Employer, Learning and development opportunities.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 12th of May 2022.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking 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:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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
Novartis Technical Operations
NTO QUALITY
Slovenia
Ljubljana
Quality
Full Time
Regular
No
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343946BR

Regional eCompliance Manager (m/f/d)

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