Senior QA Manager

vor 1 Woche

Kundl, Tirol, 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, 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


This position ensures all aspects of manufacturing, testing, release and distribution for key biologics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.


Your key responsibilities:

Your responsibilities include, but are not limited to:

  • Provides direction and formulates strategies to maintain and improve the external supplier quality oversight. Establishes and maintains quality relationship with strategic suppliers.
  • Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers.
  • Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs.
  • Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews.
  • Incident management: Manages all quality issues (complaints, deviations, OOX).
  • Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure.
  • Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers
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:

  • Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
  • Fluent in speaking / writing in English
  • Min 8 years of experience in in the pharmaceutical industry. Min 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics.
  • Min 5 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management.
  • Expert in communication and advanced negations skills. Advanced decisionmaking skills.
  • Basic leadership skills.

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 € 73,112.90/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.

Sandoz

  • Division
  • SANDOZ
  • Business Unit
  • Quality STO
  • Location
  • Austria
  • Site
  • Kundl
  • Company/Legal Entity
  • Sandoz GmbH
  • Functional Area
  • Quality
  • Job Type
  • Full Time
  • Employment Type
  • Regular
  • Shift Work
  • No

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