QA Senior Manager Biosimilars (d/f/m)

Job Description Summary

Job Description

30+ is the current number of planned projects in the Development of Biosimilar medicine for the treatment of cancer, autoimmune diseases, diabetes and others. If you are interested in working in a dynamic, interdisciplinary and international environment and if you are interested in making sure our products meet high quality standards, join us.

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 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.

As QA Senior Manager Biosimilars (d/f/m) you will be responsible for the development and verification of the internal quality system compliance to mitigate risks related to product/API quality and to reduce costs associated to poor product quality, pursuant to the law, internal regulations, good practices and business objectives

Join us as a Founder of our ‘new’ Sandoz and Lek! 

Your key responsibilities:

Your responsibilities include, but not limited to:

• Responsible for the development of an internal quality system for Biosimilar Development projects and ensuring Quality compliance as per pharmaceutical regulations, good pharmaceutical practice and Sandoz requirements e.g.internal procedures and as defined in Quality Assurance Agreements with external partners (QAAs).
• Review of documentation and responsibility for giving quality guidance based on regulations and standards but give room for scientific and technical discussions.
• Responsible for the conduct of internal and external audits of the quality system (approval of suppliers, contract suppliers and contract manufacture suppliers).
• Negotiation of Quality Assurance Agreements (QAA) with external partners.
• Change and deviation management, complaint handling.
• Escalate risks and issues, as well as propose mitigating actions.
• Responsibility for ensuring timely achievement of project Quality deliverables.
• Contribute to process simplification and QMS improvements.

What you will bring to the role:

• University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
• Minimum 5 years of working experience in Biopharma quality/quality assurance or operations (i.e. Upstream / Downstream process development, Drug product development, analytics).
• Excellent communication and organizational skills.
• Excellent skills in identifying issues and solving problems.
• Excellent & detailed knowledge of GMP-regulations. 
• Fluent in English.
• Knowledge of Microsoft Office.

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 permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 9. 2. 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

#Sandoz #BioRampUp

Skills Desired