Eso Sm Quality Assurance Manager

vor 5 Monaten

Kundl, Österreich Sandoz GmbH Vollzeit

**ESO Quality Assurance Manager (d/f/m), Kundl, Tyrol, Austria**

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz

**Your key responsibilities**:
**Please note that this is a temporary position with a fixed term of 2 years.**

Your responsibilities include, but are not limited to:

- Acts as Single Point of Contact for all quality related activities at assigned external suppliers and provides the quality presence and input to technical meetings with the external suppliers.
- Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events.
- Further ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure
- Assesses quality trends and drives continuous improvement. Critically assess the performance of the product and processes performed at the external supplier. Escalates any issues or instances of instability as necessary.
- Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures.
- Manages all quality issues (complaints, deviations, OOX) and ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.
- Leads and supports all QA tasks required for new product launches and transfers and any other global initiatives with the scope of external manufacturers.

Diversity and 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 Requirements**:

- Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
- Min 5 years of experience in in the pharmaceutical industry. Good knowledge of the manufacturing of sterile pharmaceuticals.
- Min 3 years of experience in operational quality assurance. Advanced knowledge of cGMP requirements for major regulated markets (EU, US). Basic experience with FDA, EMEA and other Health Authorities. Advanced understanding of risk management. Basic understanding of project management.
- Excellent communication & negations skills with decision-making ability skills.
- Fluent in speaking / writing in English

**Desirable requirements**:

- Ability to work in a matrix organization
- German language is required.

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**Imagine what you could do here at Sandoz
**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.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 € 60,212.18/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.

We are open for part-time and job sharing models and support flexible and remote working where possible.

**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.

Sandoz
- Division
- SANDOZ
- Business Unit
- Quality STO

  • Eso Sm As&t Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Analytical Science & Technology Manager (AS&T) - External Supply Operations SM (d/f/m), Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with...

  • AS&T Manager – ESO Biosimilars

    vor 1 Monat

    Kundl, Tirol, Österreich Novartis Vollzeit

    Transformative Period for SandozSandoz is undergoing an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and...

  • AS&T Manager – ESO Biosimilars

    vor 6 Monaten

    Kundl, Österreich Novartis Vollzeit

    Analytical Science & Technology Manager (AS&T)– External Supply Operations ESO Biosimilars (d/f/m), Kundl, Austria or Slovenia SiteSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its...

  • AS&T Manager – ESO Biosimilars

    vor 3 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Transformative Quality Leadership OpportunitySandoz, a global leader in sustainable Generic and Biosimilar medicines, is seeking a highly skilled AS&T Manager to join our External Supply Operations team. As a key member of our Quality organization, you will be responsible for executing and maintaining our quality system, ensuring compliance with regulations,...

  • As&t Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Analytical Science & Technology Manager (AS&T) - External Supply Operations ESO Biosimilars (d/f/m), Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus,...

  • QA Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Manager (d/f/m) ESO, Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives,...

  • Quality Assurance Expert

    vor 4 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description SummaryAs a Quality Assurance Operations Expert at Novartis, you will be responsible for ensuring that all production and testing activities in your area of responsibility are executed according to cGxP standards. This includes oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and...

  • Technical Manager Ms&t Eso-bio Drug Product

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Senior Technical Manager Ms&t Eso-bio Drug Product

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Quality Assurance Specialist

    vor 3 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Job Description SummaryAs a QA Operations Expert at Novartis, you will be responsible for ensuring that QA operations activities are executed according to cGxP standards. This includes oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.Main Responsibilities:Oversight of all production...

  • Quality Assurance Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    QA Manager (f/m/d), Sandoz Development Center, Kundl, Austria **Your key responsibilities**: Your responsibilities include, but are not limited to: - Implementation, maintenance and development of quality systems for SDC Kundl (small molecules) - Supervision and harmonization of all quality-related activities within the SDC - Ensuring compliance with...

  • Global GMP Quality Assurance Specialist

    vor 1 Monat

    Kundl, Tirol, Österreich Novartis Vollzeit

    Global GMP Quality AuditorSandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines.As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for Sandoz...

  • Global GMP Quality Assurance Specialist

    vor 4 Wochen

    Kundl, Tirol, Österreich Novartis Vollzeit

    Global GMP Quality AuditorSandoz is undergoing a transformative period as a global leader in sustainable Generic and Biosimilar medicines.As an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for Sandoz...

  • Senior QA Manager/qp

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior QA Manager/QP(d/f/m), Sandoz GmbH, Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business...

  • Supply Operation Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Technical Manager Ms&t Eso-bio

    vor 5 Monaten

    Kundl, Österreich Sandoz Vollzeit

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Site Quality Head

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Site Quality Head (d/f/m), Kundl, Tirol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives,...

  • QA Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **QA Manager (d/f/m), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance...

  • Senior QA Manager

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Senior QA Manager (d/f/m), Kundl, Tyrol, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives,...

  • Quality Head Large Molecules and Injectables

    vor 5 Monaten

    Kundl, Österreich Sandoz GmbH Vollzeit

    **Quality Head Large Molecules and Injectables (d/f/m), Global Quality STO, Kundl, Austria** Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater...