Manage projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is maintained in TRD.
Manage portfolio of projects, support a discipline and/or provide a service. If applicable, may provide functional expertise in area of responsibility.
Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. With training and specific delegation may also approve relevant deliverables.
Support project related activities (e.g. interpret results, evaluate data, draw relevant conclusions).
Perform inspections and audits as required
Contribute to the evaluation of new QA tools.
Write GMP relevant documents in own area of responsibility (e.g, SOPs with global applicability).
Supervise 0-3 direct/indirect reports or a team
Provide support to TRD line functions in GMP compliance related issues (e.g. training, document management)
Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines. If managing associates, ensure same for them
Support project management functions as a subteam member or in preparation for a PAI
Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process
Technician with continuing education (EU)or BS/MS (US) or equivalent Basic degree in scientific or relevant discipline (BS or equivalent)
Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
Business fluent in English (oral and written) required; fluent in site-language desirable
At least 2 years of relevant experience
Ability to negotiate and communicate
Sound scientific, technical and regulatory knowledge in a specific area.
Expertise of cGMPs, working knowledge of safety and environmental regulations and guidelines
Profound knowledge of drug development
Organizational skills and ability to analyze and evaluate GMP
Attractive location, Pharma-hub Basel
Act as a Project Consultant in a global pharmaceutical company
Strong possibility of project extension as well as follow-up projects