Summary
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? https://www.novartis.com/about/strategy/people-and-culture
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