QA Manager ESO FDF (d/f/m)

Job Description Summary

Job Description

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 and Lek 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.

We are looking for QA Manager ESO FDF (d/f/m) who will be responsible for managing quality aspects at external suppliers for Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement,  regulatory  requirements and the Sandoz Quality Manual and is conducted according to the relevant SOPs.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Ensuring that the external supplier provides the necessary product inspection or product data on an annual basis, in accordance with the provisions of the relevant quality contract, and that it provides a critical assessment of product and process performance and contributes this assessment to the report on an annual basis. 
• Support to the launch process: quality assurance assessment, handover of the quality assurance checklist, review of new inventory units and coordination with different functions as necessary. 
• Implementation and maintenance of a local quality system and general procedures defining all processes for the management of external suppliers. 
• Ensure that the Quality Assurance Manager and the Supplier Relations Manager are regularly informed of any critical and major problems that could adversely affect the quality of the product from the external supplier. 
• In cooperation with the Supplier Relations Manager, he/she provides guidance, formulates strategies and takes decisions to ensure the effective operation of the external supplier as a whole.
• Participates in the reporting of external supplier quality assurance activities - this includes risk assessment, reporting and management of defined key performance indicators.
• Ensures that a coordinated interface is maintained with other functions within Sandoz that also work with external suppliers, namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Registrations, Sandoz Group Quality Assurance (GQO) activities, etc.
• It is involved in specific projects and takes care of implementation and monitoring of all aspects.

Essential Requirements:

• University degree in pharmaceutical, chemical or other appropriate sciences
• Fluent knowledge of English.
• Knowledge of Microsoft Office.
• 1 year of experience in quality management, quality control, manufacturing, regulatory or other relevant professional field.

You’ll receive:

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. 

Possible job locations: Slovenia (Ljubljana) 

We offer temporary contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by April 4th, 2025.

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.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

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Skills Desired