2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
The Manager, QA Technical Research Development, manages projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards.
Your Key Responsibilities: * Leads or supports early phase projects or support more complex projects with mentoring. * Ensures that compliance with cGMP is maintained in TRD CGT. * Supports a discipline and/or provide a service individually or within a team of associates. * May provide functional expertise to Line Unit and other QA Units in area of responsibility. * Writes, reviews, decides on approval and/or release of GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables. * Manages project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility. * Supports Project management functions as a project team member. * Provides quality support and guidance to TRD line functions in GMP related topics as per area of responsibility. * Provides support and guidance to TRD line functions to implement TRD Development Quality Practices (DQP) for non-GMP activities. * Complies with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). * Other relates duties as assigned.