Senior Global Aseptic Processing Expert

**28,000** associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- In the role you will act as an Expert for Aseptic processing (M/F/d) within the Novartis manufacturing network (includes Advanced therapies and Large Molecules / CMO sites).**Your key responsibilities**:

- Leading cross site/platform and network projects and harmonization initiatives as assigned.
- Provide expert advice and appropriate technical support to ensure site readiness for Health Authority and GGA inspections by supporting sites in their preparation, up to and including hands on preparation of materials (i.e. storyboards for complex cases, etc.).
- Ensure quality actions are executed and the overall plans are closed per the required timelines and that future quality plans are aligned with global initiatives.
- You will be the main responsible person for optimization of aseptic techniques, cleaning and disinfection programs, microbiological monitoring and sterilization techniques between sites and x-platform within the Novartis manufacturing network.
- As Subject matter expert in microbiological topics, providing ad-hoc support to the sites of the platform and within the network.
- Acting as the Follow Up Responsible Person (FURP) for actions triggered by internal and external audits.
- Leading escalations for specific topics (i.e. Microbial contaminations, sterility issues, etc.) with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.e. QA operations, QA compliance lead, QC/AS&T lead).

**Commitment to Diversity & Inclusion**:

- 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 Chemistry, Pharmacy, Microbiology or another related science. PhD is desirable.
- 15 years experience in management and leadership roles in the pharmaceutical industry, preferably in a FDA-regulated environment and in QA Operations & Compliance of a strategic Site or a global role. Pharma production experience are necessary.
- Deep understanding of microbiology and aseptic processes.
- Experiences with Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
- Fluent English language (written and spoken), German is a plus.
- People management and project management experiences.
- Ability to operate in a global matrix environment and to be resilient.

Possible job locations: Austria, Slovenia, Czech republic, Spain or Poland.**You’ll receive**

Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home and many other benefits, related to the legal entity you’ll be employed at.**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 € 73.187,94/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 (relevant only for Austria).
- 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.-
**Division**
- Novartis Technical Operations

**Business Unit**
- NTO QUALITY

**Country**
- Austria

**Work Location**
- Schaftenau

**Company/Legal Entity**
- Sandoz GmbH

**Alternative Country 1**
- Slovenia

**Alternative Country 2**
- Czech Republic

**Alternative Country 3**
- Spain

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

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