Quality Manager
vor 1 Woche
Job ID REQ Nov 19, Schweiz Summary Location: Basel, Switzerland #onsite Role Purpose: Manage independently technical development projects and related processes to support departmental portfolio, projects and objectives according to agreed timelines and standards within Technical Research & Development (TRD About the Role Major accountabilities: Manage project related activities 8e.g. TRD product portfolio, processes, quality initiatives, Quality risk Assessment) as per area of responsibility Support Project management functions as a project team member Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.) Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation Review of master and executed batch record Write, review and complete GMP relevant documents (e.g. CoAs, BRR, checklists, risk assessments) Support audits and inspections Can act as QA SPOC for assigned CMOs Key performance indicators: In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections Maintain sound working relationship with internal customers and external partners Meet quality and timelines in area of responsibility Feedback from team members Act in accordance with Novartis standards in particular: cGMP, ethical, health safety and environment (HSE), and information security (ISEC) Minimum Requirements: Work Experience: Masters Bachelor/Technician (>5 years pharma) Critical Negotiations. Project Management. Collaborating across boundaries. Skills: Oligo manufacturing and analytics highly desired Sterile manufacturing highly desired Good knowledge of cGMP, working knowledge in technical development, production or QA Good organizational and decision-making skills Good and proven ability to analyze and evaluate cGMP compliance Agility Continuous Learning Influencing Skills. Languages : Fluent English required (oral & written) Good skills in site (German) desired (oral) Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Division Development Business Unit Quality Standort Schweiz Seite Basel (City Company / Legal Entity C028 (FCRS = CH028) Novartis Pharma AG Functional Area Quality Job Type Full time Employment Type Regular Shift Work No Apply to Job Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Job ID REQ (Senior) Quality Manager - TRD NCE QA Apply to Job
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