347662BR
Sep 14, 2022
Austria

Job Description

Quality Integration Project Lead BD&L (f/m/d), Schaftenau, Tirol, Austria

766 million! That’s how many lives our products touch. And in this role you will lead quality integration projects to make even more medicines available to patients through integration of acquired or in-licensed assets into Novartis.

The Quality Integration Project Lead for Global Drug Development BD&L programs will lead and support global Technical Research & Development (TRD) and Global Development Quality (GDQ) project teams in all quality-related topics and questions related to the integration of assets into TRD. You will align with the integration strategy of the global integration office and develop project strategies in alignment with TRD to ensure the quality of results within the integration project. In addition, you will coordinate inspection and submission preparations for TRD to ensure teams and projects are submission & inspection ready.


Your key responsibilities:

Your responsibilities include, but are not limited to:
• Lead and guide TRD/TRD QA on integration strategy in alignment with the global integration office and in compliance to cGMP guidelines and internal procedures
•Represent TRD QA globally in TRD integration/sub-teams, as well as at global quality board meetings and project development gate meetings
•Act as GDQ Quality Integration Lead for integrations with primary scope on TRD activities, with additional GDQ integration responsibilities
•Ensure quality oversight on the assigned integration projects with strong quality guidance, scientific and technical expertise
•Work across TRD QA functions and drive TRD and TRD QA to complete Line Function & QA integration plans incl. transfer of 3rd parties
•Work with TRD QA P&E and GDQ G&PE for Quality Management System integration
•Proactively communicate overall project strategy, key issues/risks and any other critical topics to the appropriate management level, to the integration office, to the TRD project leader
•Prepare and guide TRD integration teams for Mock- Pre-Approval Inspection and Pre-Approval Inspection in the frame of the preparation process and submission preparation

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:
•Bachelor degree with 10 years’ pharmaceutical quality/operations or a Master degree with 5 years pharmaceutical quality or operations' experience
•Fluent English required (both oral & written) with German as an advantage
•Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control
•Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of Reg CMC requirements for Health Authority submissions
•Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments
•Experience in Technical Operations or equivalent external experience is preferred
•Ability to contribute to matrix teams with the necessary critical thinking, quality awareness and implementation skills


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 €66,526.88 per 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.


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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347662BR

Quality Integration Project Lead, BD&L (f/m/d)

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