Job Description Summary
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!
Job Description
Your responsibilities include, but are not limited to:
- Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.)
- Provide needed support to meet the applicable Sandoz and regulatory requirements for GxP regulated computerized systems projects.
- Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
- Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
- Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
- Review and approve the GxP Changes and the associated deliverables.
- Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
- Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions.
- Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.
- Review and approve the Infrastructure Qualification Project Deliverables, Infrastructure Operational Changes and the associated deliverables.
- Perform supplier qualification assessment activities Provides audit support as assigned and in case of CAPAs, provides the required Quality support.
What you’ll bring to the role:
Essential Requirements:
- Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent
- Fluency in English (oral and written), additional language(s) a plus
- Around 5-8 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry or similar within particular in regulated functions such as IT Quality and Compliance
- Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments
- Experienced in the operational management of GxP solutions including its related technologies to support the operation
- Successful cross-divisional/functional work with complex international teams
- Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
- Ability to effectively interact and present to Management
- Ability to influence without hierarchical authority and build trusted partnerships
- Self-starter with experience in initiating and delivering projects and processes
- Excellent communication, negotiation, facilitation, interpersonal skills and critical thinking.
- Dedication, sincerity, flexible and within an attitude of “make it happen” is preferred.
Desirable requirements:
- Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)
- Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space
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!
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 € 64.023,54/year (on a full time basis). In most cases, the actual salary will be 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.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Skills Desired
Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Project Management
