Senior QA Expert

vor 2 Wochen


Langkampfen T, Österreich Novartis Vollzeit

**Senior QA Expert - External Relationship Manager Quality (f/m/d), Schaftenau, Austria**

Nr. 1 Support the leading Novartis Biotech Campus within Novartis Operations Large Molecule manufacturing network in Kundl/Schaftenau in dealing with customer relationship in daily business. Represent the end-to-end Biologics and Biosimilar manufacturing Biotech Campus in the interface to external customers on all quality related tasks and obligations.
A External Relationship Manager Quality is responsible to facilitate day-to-day information exchange on quality topics between operational units in Novartis manufacturing units and the respective customer accounts. The goal is to establish a Quality SPOC for an internal manufactured portfolio and maintain a pro-active info exchange on high level to achieve customer satisfaction.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Being the single point of contact for Novartis internal units in quality to fulfill the basic requirements outlined in QAAs with external customers
- Participate in internal operational meetings to extract all relevant information from day-to-day operations to be shared with key-customers
- Independent and pro-active identification, sharing and tracking of quality related aspects in the business relationship between customer and Novartis as CDMO
- Act as contact for external customers for operational requests related to quality aspects by receiving requests and setting up lean strategy to provide response in time and to customer satisfaction
- Close tracking of inquiries in both directions to facilitate progress of basic quality processes. E.g. change control, requiring input from internal and external parties
- Establish and maintain monitoring of key-performance indicators of the relationship to external customers
- Participate in management meetings with contract giver representing Novartis Quality Organization
- Foster to harmonize Q activities within CDMO organization

**Commitment to Diversity & Inclusion**:

- We are 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:

- Academic degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- Fluent knowledge of English language (written and spoken), German is an advantage
- At least 5 years or more experience in different operational areas of Biologics or Biosimilar manufacturing business, ideally covering API and aseptic filling.
- Strong quality background (QA Operation) and good sense in respect to prioritization.
- Strong leadership skills with excellent interpersonal, communication and negotiation abilities
- Independent work-style and decision making mindset
- Flexibility to work in a fast paced, quickly changing work environment with several workstreams running in parallel
- Ability to operate in a unique interface understanding needs and expectation on both ends and finding the best solutions

**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 € 73,12.90/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, co



  • Langkampfen, T, Österreich Novartis Vollzeit

    **Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    395175BRQA Operations Expert (M/F/d) - 50%:AustriaAbout the roleLocation: Austria, Tyrol, Schaftenau #LI-HybridWe We are seeking a QA Operations Expert (M/F/d) to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the existing quality...

  • QA Compliance Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    QA Compliance Expert (f/m/d), NVS, Schaftenau, Austria100% This is what each team member in the QA Compliance Team Drug Product Schaftenau (DPS) grants for our patients and customers. As a QA Compliance Expert (M/F/d) you assure, that the quality requirements of our production buildings and facilities are met. You are part of an engaged and motivated team...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Argentina Vollzeit

    Job ID BR- Mar 10, 2023- Austria**Job Description**:**QA Operations Expert (Microbiology) (m/w/d), Tirol, Schaftenau, Österreich**12 Produkte in der Pipeline, 4500 Chargen und es werden immer mehr Als Teil unseres QA-Teams unterstützt du uns dabei, diese Herausforderung jeden Tag aktiv und mit den neuesten Technologien zu meistern und so das Ziel zu...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    **QA Operations Expert (Microbiology) (m/w/d), Tirol, Schaftenau, Österreich**12 Produkte in der Pipeline, 4500 Chargen und es werden immer mehr Als Teil unseres QA-Teams unterstützt du uns dabei, diese Herausforderung jeden Tag aktiv und mit den neuesten Technologien zu meistern und so das Ziel zu erreichen, qualitativ hochwertige Produkte für Patienten...

  • QA Operations Expert

    vor 2 Wochen


    Langkampfen, T, Österreich Novartis Vollzeit

    392415BR **QA Operations Expert (M/F/d)**: Austria **About the role** Location: Austria, Tyrol, Schaftenau #LI-Hybrid We We are seeking a **QA Operations Expert (M/F/d)** to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the existing...

  • QA Operations Expert

    vor 2 Monaten


    Langkampfen, T, Österreich Novartis Vollzeit

    **QA Operations Expert (Microbiology) (m/w/d), Tirol, Schaftenau, Österreich** 12 Produkte in der Pipeline, 4500 Chargen und es werden immer mehr! Als Teil unseres QA-Teams unterstützt du uns dabei, diese Herausforderung jeden Tag aktiv und mit den neuesten Technologien zu meistern und so das Ziel zu erreichen, qualitativ hochwertige Produkte für...

  • QA Operations Expert

    vor 2 Monaten


    Langkampfen, T, Österreich Novartis Vollzeit

    393585BR **QA Operations Expert**: Austria **About the role** **Location**: Novartis, Schaftenau, Austria **About the Role**: In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support...

  • QA Operations Expert

    vor 17 Stunden


    Langkampfen, T, Österreich Novartis Vollzeit

    393585BR **QA Operations Expert**: Austria **About the role** **Location**: Novartis, Schaftenau, Austria **About the Role**: In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    395175BR **QA Operations Expert (M/F/d) - 50%**: Austria **About the role** Location: Austria, Tyrol, Schaftenau #LI-Hybrid We We are seeking a **QA Operations Expert (M/F/d)** to help us with the implementation of quality assurance tasks such us release process of compounding / filling / inspection / packaging products and further development of the...


  • Langkampfen, T, Österreich Novartis Vollzeit

    393879BR**Senior QA Operations Specialist (m/w/d)**:Austria**About the role****Senior QA Operations Specialist (m/w/d), Drug Substance Schaftenau, Tirol, Österreich****Die Position**:In dieser Rolle werden Sie in Quality Assurance Operations Team arbeiten und direkt an den Quality Team Lead von QA Operations berichten.**Ihr Verantwortungsbereich**:Ihre...


  • Langkampfen, T, Österreich Novartis Vollzeit

    386526BR**Senior QA Operations Specialist, Teilzeit (m/w/d)**:Austria**About the role****Senior QA Operations Specialist, Teilzeit (m/w/d), Schaftenau, Tirol, Österreich****Die Position**:13 kommerzielle Produkte und ein geplanter Ausbau der DPS macht die Vielseitigkeit des Drug Product Produktionsstandorts in Schaftenau aus.**Ihr...

  • QA Compliance Expert

    vor 3 Wochen


    Langkampfen, T, Österreich Novartis Vollzeit

    **QA Compliance Expert (f/m/d), NVS, Schaftenau, Austria** 100%! This is what each team member in the QA Compliance Team Drug Product Schaftenau (DPS) grants for our patients and customers. As a QA Compliance Expert (M/F/d) you assure, that the quality requirements of our production buildings and facilities are met. You are part of an engaged and motivated...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    393585BRQA Operations Expert:AustriaAbout the roleLocation: Novartis, Schaftenau, AustriaAbout the Role:In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Argentina Vollzeit

    Job ID BR- Ene 18, 2023 AustriaJob Description:QA Operations Expert (f/m/d), Quality, Schaftenau, AustriaIn 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices...

  • QA Operations Expert

    vor 1 Woche


    Langkampfen, T, Österreich Novartis Vollzeit

    QA Operations Expert (f/m/d), Quality, Schaftenau, AustriaIn 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide. As part of our team,...


  • Langkampfen, T, Österreich Novartis Vollzeit

    **QA Operations Expert Drug Product (M/F/d), Schaftenau, Österreich**12 Produkte in der Pipeline, 4500 Chargen und es werden immer mehr Als Teil unseres QA-Teams unterstützt du uns dabei, diese Herausforderung jeden Tag aktiv und mit den neuesten Technologien zu meistern und so das Ziel zu erreichen, qualitativ hochwertige Produkte für Patienten auf der...


  • Langkampfen, T, Österreich Novartis Vollzeit

    393879BR **Senior QA Operations Specialist (m/w/d)**: Austria **About the role** **Senior QA Operations Specialist (m/w/d), Drug Substance Schaftenau, Tirol, Österreich** **Die Position**: In dieser Rolle werden Sie in Quality Assurance Operations Team arbeiten und direkt an den Quality Team Lead von QA Operations berichten. **Ihr...


  • Langkampfen, T, Österreich Novartis Vollzeit

    386526BR **Senior QA Operations Specialist, Teilzeit (m/w/d)**: Austria **About the role** **Senior QA Operations Specialist, Teilzeit (m/w/d), Schaftenau, Tirol, Österreich** **Die Position**: 13 kommerzielle Produkte und ein geplanter Ausbau der DPS macht die Vielseitigkeit des Drug Product Produktionsstandorts in Schaftenau aus. **Ihr...


  • Langkampfen, T, Österreich Novartis Vollzeit

    386526BR **Senior QA Operations Specialist, Teilzeit (m/w/d)**: Austria **About the role** **Senior QA Operations Specialist, Teilzeit (m/w/d), Schaftenau, Tirol, Österreich** **Die Position**: 13 kommerzielle Produkte und ein geplanter Ausbau der DPS macht die Vielseitigkeit des Drug Product Produktionsstandorts in Schaftenau aus. **Ihr...