Associate Director Global GxP/Quality Incident Management (f/m/d)

Oct 11, 2021

Job Description

Associate Director Global GxP/Quality Incident Management, Ljubljana, Slovenia

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

We are seeking for a GxP and Quality expert with strong management skills to direct cross-functional teams and with strong communication skills to interact with internal stakeholders and external parties on global level, including Health Authorities.

In this role you will support the strong Novartis Quality Organization in managing GxP and Quality Incidents in a cross-functional end to end process on a global level.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Manage GxP/Quality Incidents in an end to end process that require cross-functional guidance and coordination as well as alignment on global level to achieve consistent cross-functional decisions across multiple sites, entities and countries
• Support and arrange the initiation of Health Authority communication on a global level
• Support the definition and drive the implementation of corrective and preventive measures related to GxP/Quality incidents on global level, this includes also market actions, if required.
• Facilitate creation of knowledge repositories and roll out of lessons learned; facilitate the maintenance of global incident management processes and procedures
• Collaborate across functions in resolving GxP/Quality Incidents and preventing recurrence. Support related GxP/Quality incident prevention activities across the entire organization.

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:
• Collaborative working style and strong communication skills
• Customer satisfaction.
• Jobs done on time, following the specified cycle time.
• Consistent compliance with GxP and quality guidelines as well as with Health, Safety & Environment guidelines and Standard Operating Procedures

Desirable requirements:
• University degree in the pharmaceutical/live science field such as but not limited to a pharmacist, biochemist, microbiologist or other specialized biologist or chemist
• Multiple years (approximately min. 6 years) of relevant thought experience in the pharmaceutical industry (Quality, Manufacturing or Development), with strong experience in the Quality area (GxP-Compliance, Quality Assurance and/or Control)
• Experience in conducting end-to-end management of quality incidents
• Experience related to biologics (including cell and gene therapy) and classical pharmaceuticals (various dosage forms, including steriles), thought understanding of pharmaceutical manufacturing processes, analytical procedures as well as Quality Management systems
• Knowledge in and experience with major international pharmaceutical regulations (e.g US FDA, EMA, Anvisa, ICH, WHO) and with the related Health Authorities (e.g. US FDA, EMA, PMDA, TGA, Anvisa).
• Good understanding of international pharmaceutical regulatory processes
• Strong analytical thinking
• Business fluent in English (verbal and in writing); advanced skills in a second internationally frequently used language
• Strong skills in applying IT tools and software programs like MS Excel, Powerpoint, Word, etc.
• Profound knowledge of pharmaceutical business in general

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 25th of October 2021.

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:

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:
Novartis Technical Operations
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Associate Director Global GxP/Quality Incident Management (f/m/d)

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