Manager Quality Systems

Aperçu SUMMARY With 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. Responsibilities include the monitoring of site compliance, the management of core quality processes and administration of electronic quality management systems, including documentation and training, according to quality policies, cGMP and applicable regulations. DUTIES AND RESPONSABILITIES • Monitor the Bioplant quality compliance. • Identify and escalate risk areas. • Prepare the QMR data and chair the meeting. • Represent Bioplant QA in Global Quality systems initiatives. • Participate in or lead continuous improvement projects, welcoming diverse perspectives and inclusive collaboration. • Lead the Bioplant Quality champion community across all departments. • Lead the daily eQuality System administration for the Bioplant. • Manage the assigned core quality processes: o Quality management review, o Documentation, archiving & training, o Deviation & CAPA, o Change Control, • Lead inspection backrooms and act as scribe when required. • Act as Primary site SME for assigned core Quality processes. • Manage the QA System team related to QS activities (i.e. documentation archiving, on boarding of new hires, training maintenance, users support, QMS training) • Manage and organize the activities to ensure compliance use of QMS • Act as Quality Champion for the Bioplant QA department to drive a high level of quality in the department: o Monitor and report quality compliance indicators for QA department o Chair Quality compliance reviews in the department o Implement quality compliance initiatives in the department in collaboration with QA and the bioplant quality champion community o Coach and support other team members for quality compliance matters (such as deviation and changes management) o Coordinate the department inspection readiness • Act as a primary site SME for Artificial Intelligence projects related to Quality Systems. • Participate to internals’ audit and Gembas. • Act as QA approver for at least document changes, deviation, CAPA. • Drive resolution of major quality issues. • At all times work in a right first time and site inspection readiness approaches • At all times work in view of the site readiness for regulatory inspections (Swissmedic and International). • Contribute positively to a strong culture of business integrity and ethics. • Act within compliance and legal requirements as well as within company guidelines. • QA representative for IA topics QUALIFICATION • Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering • Relevant years of experience in Quality Assurance in a GMP environment • Proficiency with electronic Quality System administrationAdvanced expertise in good practice requirements GMP as well as biopharmaceutical industry regulations and standards with Quality Systems • Experience in health authorities inspections • Ability to exercise quality decisions in a pragmatic and compliant decisions • Strong result orientation and committed team member • Must speak, read & write in both English and French • Excellent written and verbal communication skills DELEGATION The position can delegate tasks and duties relative to Quality Systems to Quality Associate Directors. Disclaimer: 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. We Respect Your Privacy Learn more at: http://www.incyte.com/privacy-policy The 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. During 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. You 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. You 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). Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Biopharmaceutical company discovering and developing small molecule drugs in oncology and inflammation. Headquartered in Wilmington, DE.

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