Global QMS Senior Manager - Change Control & Master Data Management (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 Global QMS Senior Manager - Change Control & Master Data Management your main responsibilities will be to ensure compliance and further development of the Change Control & Master Data Management systems. This includes supporting projects, maintaining and reviewing the systems, and reporting performance and quality indicators. Your role also involves implementing processes that meet regulatory requirements for Sandoz's global product portfolio. Join us as a Founder of our ‘new’ Sandoz and Lek!  

Your key responsibilities: 

Your responsibilities include, but not limited to: 

• Act as Quality System Owner for Change Control as well as for Master Data Management.
• Drive Quality System simplification, harmonization, local use and implementation and continuous improvement through cross-functional collaboration with Process Owners and Functional Representatives.
• Act as a Business System Owner for the validated GxP Document Management IT systems used across Sandoz – including maintenance and continuous enhancement.
• Provide guidance, training and oversight to users. Align Global Systems and Standards through direct interface with representatives across the organization.
• Lead and/or participate in key QMS projects or initiatives where needed and ensure that defined quality elements and compliance requirements are addressed and that the roll-out to impacted Functions or entities is achieved.
• Maintain knowledge of current industry trends and Health Authority expectations, monitor and report trends, drive risk assessments and drive improvements initiatives.
• Develop in the team and implement quality initiatives across organization.

What you will bring to the role: 

• University degree in Pharmacy, Chemistry, Engineering or equivalent related discipline.
• Minimum 8 years’ experience in Pharmaceutical, Chemical or Biological Operations.
• Broad experience in Quality processes and underlying regulatory requirements and industry standards/best practices.
• Very good knowledge of (Sandoz) QMS principles.
• Leadership and Project Management skills to ensure successful implementation of projects or initiatives.
• Experience in an international matrix organization, as well as curiosity and agility to be able to adapt to fast moving environment.
• Good communication skills.
• Fluent knowledge of English (written and spoken).

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) , Barcelona (Spain), Kundl (Austria).

We offer permanent contract with 6 months of probation period. You are kindly invited to submit your application in English language, including CV, by 17 February 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 

Skills Desired