May 27, 2022

Job Description

Director, Global GxP/Quality Incident Management, Schaftenau, Austria

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 direction and coordination as well as alignment on global level
• Drive consistent cross-functional decisions across multiple sites, entities and countries
• Support, initiate and drive communication with Health Authorities 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.
• Drive design and creation of knowledge repositories and roll out of lessons learned; support and drive the maintenance of global incident management processes and procedures
• Collaborate across functions in resolving GxP/Quality Incidents and preventing recurrence. Drive 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:
• University degree in the pharmaceutical/life science field such as but not limited to a pharmacist, biochemist, microbiologist or other specialized biologist, biotechnologist or chemist
• Multiple years (approximately min. 12 years) of relevant thought experience in the pharmaceutical industry (Quality, Manufacturing or Development), with strong experience (several years) in the Quality area (GxP-Compliance, Quality Assurance and/or Control)
• Experience in conducting end-to-end management of quality incidents
• Experience related to classical pharmaceuticals (various dosage forms, including steriles) and biologics (including cell and gene therapy), thought understanding of pharmaceutical manufacturing processes, analytical procedures as well as Quality Management systems
• Knowledge in and experience with major international pharmaceutical regulations (US FDA, EMA, ICH, WHO, etc.) and with the related Health Authorities (e.g. US FDA, EMA, PMDA, TGA, Anvisa, etc.).
• Good understanding of international pharmaceutical regulatory processes and profund knowledge of pharmaceutical business in general
• Business fluent in English (verbal and in writing), advanced skills in a second internationally frequently used language; willingness to travel
• Strong analytical thinking and strong skills in applying IT tools and software programs like MS Excel, Powerpoint, Word, etc.

Why Novartis?

766 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!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 69.735/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job sharing models and support flexible and remote working where possible.

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.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Full Time
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Director, Global GxP / Quality Incident Management (f/m/d)

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