We are a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
-Ensure implementation of applicable Quality Standards & governance processes through the implementation of the Novartis Quality Manual and Policies. Ensure that regulatory controls are in place in relevant process steps -Ensures adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements -Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant. Ensure regularly review and assessment of KQIs at the Leadership Team level. -Ensure adequate regulatory inspection preparation, management and follow-up in the area of responsibility. Ensure communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time. -Ensure implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities. -Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes and systems. Initiate remediation activities, as necessary, to ensure ongoing compliance. -Ensures adequate processing of complaints. Establishes an efficient recall organization as well as ensure development of talent within the local Quality unit. Develop adequate succession candidates for the Quality organizations.
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.