May 03, 2022

Job Description

QA Compliance Expert (f/m/d), Novartis Technical Operations, Kundl, Austria

160 Million! This is the number of antibiotic packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year!

As QA Compliance Expert (f/m/d), you will be supporting the life-cycle management of established products and facilities and implementation of new products in providing regulatory support during evaluation and implementation of changes on site to ensure regulatory compliant implementation of changes. In addition, you will support health authority inspections and general QA compliance topics. You will be working in a multi-disciplinary team of Compliance Experts servicing an end to end Anti-Infectives Manufacturing Operation starting from the Active Pharmaceutical Ingredient and continuing to the Finished Dosage Form.

Apply now and become a part of our dynamic Anti-Infectives team!

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Primary regulatory contact for change control processes
• Provide regulatory affairs support for the QA, manufacturing and engineering, for technical as well as for product related changes
• Facilitates between site & RA CMC to support the business
• Review & approval of site-specific submission documents
• Supports the site with training to ensure adequate regulatory understanding & regulatory compliance
• Support Change Management according to the Novartis SOPs
• Handle Quality projects within area of responsibility
• Support communication with country organizations in alignment with the requirements of the Novartis Quality Manual and Policies

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:
• M.Sc. in Biology, Biotechnology, Pharmacy or other related science
• Minimum 3 years of experience in the pharmaceutical industry (beneficial: background in Regulatory Affairs)
• Strong understanding and overview of GMP requirements and site quality systems
• Proficient in English and German-spoken and written
• Good communication skills, orientated to finding solutions, collaborative and curious to learn new aspects

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!
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 € 52.204,04/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
Novartis Technical Operations
Full Time
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QA Compliance Expert (f/m/d)

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