346475BR
Jun 10, 2022
Austria

Job Description

Quality Project Manager (f/m/d), Schaftenau, Tyrol, Austria

13! This is the number of colleagues that you work with as a Quality Project Manager. Your knowledge in GMP environment is strong and you are willing to take the challenge as a QA Manager in TRD and be part of the CMC team to get new medicines on the market. Projects can be new biological entities (NBE) as well as Biosimilars and can even comprise combination products with strong interaction medical devices QA. Release to clinics is the purpose of our work.

Novartis invests heavily in development and is committed to clinical development. We are dedicated to serve the patients that need your innovative medicines. The Development QA team needs you at our beautifully located site in Schaftenau / Tyrol in Austria to accelerate one of the most diverse and innovative portfolios in the pharma industry. The company offers remote work opportunities to make your life-work balance happen.


Your key responsibilities:

Your responsibilities include, but are not limited to:
• Manage quality aspects of assigned TRD development projects, support and provide guidance on internal quality system in accordance with pharmaceutical regulations, good pharmaceutical practices and Novartis guidelines
• Closely work with Line function and finally perform QA approval for deviations and lab excursions (eg. OOX)
• Perform technical release of Drug Substance, Drug Product, Combination products for clinical supply in accordance with the written specifications and local as well as international regulations
• Write GMP relevant documents in own area of responsibility (e.g. SOPs, Quality risk assessment)
• Review and disposition of deliverables as well as approval for development project documentation (e.g. batch record, SOP, project related documentation, third party assessment)
• Promote and provide support to TRD Development line functions in GMP compliance related topics (e.g. training, document management)

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:
Essential:
• MSc in scientific or relevant discipline (e.g. pharmacy, biotechnology, chemistry, biology, physics, (chemical) engineering or related)
• Fluency in English (reading, writing & orally)
• Minimum of 2-3 years of experience in a quality management function of a pharmaceutical company
• Excellent communication and negotiation skills

Desirable requirements:
• Knowledge of the German language
• Experience in the development or manufacturing of biological or chemical drugs
• Health authority audit experience


Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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 €54,788.30 per year (on a full-time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.


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
Global Drug Development
QA GDD
Austria
Schaftenau
Quality
Full Time
Regular
No
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346475BR

Quality Project Manager (f/m/d)

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