Quality Lead – Project (d/f/m)

Job Description Summary

Job Description

Sandoz, of which Lek is also a part, 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 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 a Quality Lead - Project, you will be responsible for ensuring successful strategic leadership for all quality-related matters and ensuring that key aspects of operations are consistent with current best practices for the upcoming Biosimilars Drug Product Manufacturing Site Project. You will also be responsible for providing guidance and support to teams in your area of responsibility in accordance with legislation, internal guidelines, best 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:

• Provide leadership to Quality Team of the project and be a Quality Single Point Of Contact for the project. Comprehensive overview of the quality and compliance strategy of the investment project for the biosimilars manufacturing.
• Collaboration with key stakeholders of the investment project team, including experts in the field of production processes, quality, engineering and automation.
• Responsible person for reporting to global stakeholders on compliance with all regulatory requirements and quality criteria for the entire scope of the project.
• Participation in the development, implementation and control of the quality system in accordance with Slovenian and European legislation, the US FDA, the International Council for the Harmonization of Technical Requirements for Medicinal Products, the Convention on Pharmaceutical Inspection. Ensuring that team members' Good Manufacturing Practice (GMP) competencies are prioritized over individual achievements.
• Responsible for providing guidance to Quality team on design and qualification of state of the art testing laboratories.
• Managing strategic activities, projects, decisions, ensuring state-of-the-art production and laboratory processes.
• Ensuring that relevant inspections/audits of the project are successful.
• Establish adequately skilled, talented and motivated quality team to support the successful execution of the project as per project timelines. Creating a working environment that allows for a high level of employee engagement.

What you will bring to the role:

• Master’s or higher education level in pharmaceutical, biological, chemical, microbiological or other relevant natural sciences.
• Active knowledge of English language.
• Knowledge of Microsoft Office tools.
• Minimum of 10 years of work experience in quality, development or production or comparable positions in Biopharma / Biosimilars manufacturing environment.
• Experience of leadership role is desirable.
• Experience of working in projects is desirable.

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 November 29th, 2024. 

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

Skills Desired