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 Purpose: Manage service delivery team within Quality Operations group via demonstration of strong leadership and role modelling skills. Implement initiatives to identify, establish and maintain services related to the product quality and compliance processes. Also responsible for developing functional experts and team Managers in accordance to Sandoz people development requirements, Sandoz Values and Behaviors. The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance with regard to supplier quality assessment, computerized systems validation (CSV) and Infrastructure Qualifications, operating within the framework of regulations (GxP, 21CFR11, Annex 11 etc.) and requirements defined in the Sandoz Quality Manual and global procedures.
Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the projects and operations team on the CSV and Infrastructure Qualification related topics and related information. Reviews and/or approves the global Computerized Systems key validation and qualification deliverables as a part of the eCompliance support to the GxP projects and Infrastructure Qualification Projects. Your Key Responsibilities: Oversee the quality of project and operational activities for GxP systems, including changes, periodic reviews, deviations, and other related processes. Support the compliance of GxP-regulated computerized systems projects with all relevant Sandoz policies and regulatory requirements. Serve as the primary contact for all CSV-related matters pertaining to GxP computerized systems, acting as a liaison between IT and Business to promote a Quality Culture for eCompliance. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Build 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. In addition, 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. Conduct 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 5-8 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance You?ll receive: Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well. 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! #Sandoz Skills Desired Action-Oriented, Compliance Requirements, Continued Learning, Dealing With Ambiguity, Functional Skills, Gmp Procedures, Gxp, Industry Standards, Process Optimization, Qa (Quality Assurance), Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Novartis