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Job ID 213067BR Position Title Device Manager I - Process Division Novartis Technical Operations Business Unit NTO BTDM Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Lead and manage all technical/laboratory/processes activities and apply expertise to address design, development, operational issues for the preparation and timely delivery of Medical Devices, combination product, processes and procedures; Develop team members, Participate in teams and contribute to overall BTDM ( Biologics Technical Development & Manufacturing ) strategies and goals.
1.Ensure compliance and support all activities related to device design and commercialization processes within BTDM according to the Novartis internal quality standards, relevant regulatory requirements and the filed product quality standards.
2.Ensure communication/escalation within applicable departments and project teams to ensure device design and commercialization process requirements and outputs are consistent across BTDM sites.
3.Partner with functions within BTDM to conduct trending of data and generation of the necessary reports. Identify and address any gaps in skills, capabilities and or regulatory requirements for the device design and commercialization process.
4.Assure complete and correct documentation including keeping of deadlines (according to local KPIs) and GMP-compliance/pro-active follow-up of actions. 5.Lead training and development of on-site personnel with regards to skills and capabilities required for device design and commercialization processes.
6.Lead monitoring of device design and commercialization process reports.
7.Ownership of the process and/or combination product DHFs including updating of documents to ensure the DHF remains in a state of compliance throughout the life cycle of the product.
8.Perform other related assignments and duties as required and assigned.
9.Design, develop and implement a strategic plan to improve the device design and commercialization process.
10.Lead the development and implementation of a sustainable system for device design and commercialization process needs.
11.Lead updates to device design and commercialization SOP(s) within BTDM ensuring that it adequately describes the process to be followed, including participating and/or authoring of SOPs.
12.Support the creation, implementation and monitoring of device design and commercialization process which will ensure organizational effectiveness, business objective achievement, strategic plan performance and regulatory compliance. Minimum requirements Minimum: BS/MS or equivalent Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent). Good knowledge of English (oral and written). Desirable knowledge of site language.
1.Successfully demonstrated several years (3-5 years) experience in medical device or Pharma industry or equivalent
2.Recognized expertise in a specific area.
3.Thorough knowledge of state-of-art technology/equipment/regulation as appropriate for the role.
4.Thorough understanding of medical devices development processes and knowledge of related basic regulations
5.Ability to work in matrix environment and/or lead interdisciplinary and/or cross-cultural teams and indirectly influence team members.
6.Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
7.Strong communication skills. Strong presentation skills and scientific/technical writing skills.
8.May require up to 15% travel.