Quality Manager / Qualified Person

Job Description Summary EU Local Distribution Qualified Person for investigational medicinal products IMPs and auxiliary medicinal products AMPs Job Description Major Accountabilities: Batch certification / batch release of investigational medicinal products IMPs and auxiliary medicinal products AMPs in EU Local Distribution Collaboration with local COs (SSO, Depot, NCQ) Review and approval of quality-relevant Documentation to support batch release Ensure compliance with local and international regulations Continous improvement of QA system and processes Systematic improvement of compliance and operational level CAPA Management Support in Complaint handling Change Control Management SOP preparation and review self-reliant Project Management Reporting of technical complaints / adverse events / special case scenarios related to Novartis products Work Experience: Audit & Inspection Management Quality Management Systems Quality Assurance GxP Experience Good Manufacturing Practices (cGMP) Quality Compliance Drug Development Research Technological Expertise Complaints Management Good Laboratory Practice (GLP) Analytics Incident Management Deviation Management Corrective and Preventive Action (CAPA) Knowledge Third Party Management Change Control Management SOP (Standard Operation Procedure) Management Patient Safety Pharmacovigilance Skills: Pharmacist Qualification as a Qualified Person according to EU Legislation Languages: English Skills Desired Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .