Manager Quality Systems

ph3Aperçu /h3 h3Summary /h3 pWith a reporting line in the Quality Assurance team, this position leads the daily Quality System activities and related operations associated with the development and the maintenance of a Quality Management System for Incyte manufacturing facility in Switzerland. /p h3Duties And Responsabilities /h3 ul liMonitor the Bioplant quality compliance. /li liIdentify and escape risk areas. /li liPrepare the QMR data and chair the meeting. /li liRepresent Bioplant QA in Global Quality systems initiatives. /li liParticipate in or lead continuous improvement projects, welcoming diverse perspectives and inclusive collaboration. /li liLead the Bioplant Quality champion community across all departments. /li liLead the daily eQuality System administration for the Bioplant. /li liManage the assigned core quality processes: /li liQuality management review, /li liDocumentation, archiving training, /li liDeviation CAPA, /li liChange Control, /li liLead inspection backrooms and act as scribe when required. /li liAct as Primary site SME for assigned core Quality processes. /li liManage the QA System team related to QS activities (i.e. documentation archiving, on boarding of new hires, training maintenance, users support, QMS training) /li liManage and organize the activities to ensure compliance use of QMS /li liAct as Quality Champion for the Bioplant QA department to drive a high level of quality in the department: /li liMonitor and report quality compliance indicators for QA department /li liChair Quality compliance reviews in the department /li liImplement quality compliance initiatives in the department in collaboration with QA and the bioplant quality champion community /li liCoach and support other team members for quality compliance matters (such as deviation and changes management) /li liCoordinate the department inspection readiness /li liAct as a primary site SME for Artificial Intelligence projects related to Quality Systems. /li liParticipate to internals’ audit and Gembas. /li liAct as QA approver for at least document changes, deviation, CAPA. /li liDrive resolution of major quality issues. /li liAt all times work in a right first time and site inspection readiness approaches /li liAt all times work in view of the site readiness for regulatory inspections (Swissmedic and International). /li liContribute positively to a strong culture of business integrity and ethics. /li liAct within compliance and legal requirements as well as within company guidelines. /li liQA representative for IA topics /li /ul h3QUALIFICATION /h3 ul liBachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering /li liRelevant years of experience in Quality Assurance in a GMP environment /li liProficiency with electronic Quality System administrationAdvanced expertise in good practice requirements GMP as well as biopharmaceutical industry regulations and standards with Quality Systems /li liExperience in health authorities inspections /li liAbility to exercise quality decisions in a pragmatic and compliant decisions /li liStrong result orientation and committed team member /li liMust speak, read write in both English and French /li liExcellent written and verbal communication skills /li /ul h3DELEGATION /h3 pThe position can delegate tasks and duties relative to Quality Systems to Quality Associate Directors. /p pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p pWe Respect Your Privacy /p pLearn more at: /p pThe Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. /p pDuring the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. /p pYou may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. /p pYou can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable). /p pPlease contact if you have any questions or concerns or would like to exercise your rights. /p /p #J-18808-Ljbffr