Incyte
Director to Sr. Director, Digital Quality Management Systems Programs
Incyte, Wilmington, Delaware, us, 19894
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.Job Summary (Primary function)The Director to Sr. Director, Digital Quality Management Systems (QMS) programs leads the digitalization of the Quality Management System. The person in this role owns the electronic enterprise Quality applications across the GxPs, ensuring their evolution to best serve the patients and business needs. This role is accountable for their continuous compliance with regulations.Essential Functions of the Job (Key responsibilities)Develop and oversee the Digital Quality Management System governance model and roadmap that supports pre-clinical, clinical, manufacturing, distribution and Pharmacovigilance activities. Ensure alignment with the business needs and Quality Plan/StrategyAct as System owner of all digital GxP enterprise Quality applicationsEnsure the Digital QMS is maintained in accordance with current regulatory standards and meets corporate quality and business objectivesLeads e-systems developments and enhancements projects in collaboration with the network of Quality process owners and ITLeverage Artificial Intelligence capabilities to enhance our digital QMSDevelop and maintain digital Quality applications system administration processes, including business Continuity planningAssure Inspection readiness of digital Quality applications and be the Subject Matter Expert during Health Authorities Inspections on enterprise Quality applicationsSupport the identification of digital solutions addressing Quality business needsAct as QA lead for cross functional GxP digital applications projectsManage the business relationship with the suppliers of digital quality applicationsPromote a strong Quality culture to ensure Incyte digital applications implementation and usage is fit for intended use and ensures highest level of data integrity and complianceSupport the Global Quality leadership team in driving key Quality culture initiativesResponsible for developing and continuously improving core GxP and Quality training program, including strategy and delivery methods, fostering Incyte Culture of QualityDevelop new and innovative approaches to GxP and Quality TrainingsCollaborate with other GxP operational teams to develop a common framework for GxP trainingsCollaborate closely with IT, Quality and Operations teamsConduct Corporate Quality auditsQualifications (Minimal acceptable level of education, work experience, and competency)Advanced degree in life sciences, quality, or related field requiredMinimum 10 years in Quality Assurance in a Pharmaceutical / Medical Device Industry in an international environmentIn-depth operational experience in one area of the GxP allowing solid understanding of Business needs in terms of digital quality applicationsExcellent knowledge of US, EU, ICH GxP regulationsExperience in Managing and operating digital Quality applicationsStrong leadership, project management, and relationship building skillsAbility to communicate complex information effectively across functionsCertified quality auditorDisclaimer: 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.Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.We Respect Your PrivacyLearn more at: http://www.incyte.com/privacy-policyThe 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.
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.Job Summary (Primary function)The Director to Sr. Director, Digital Quality Management Systems (QMS) programs leads the digitalization of the Quality Management System. The person in this role owns the electronic enterprise Quality applications across the GxPs, ensuring their evolution to best serve the patients and business needs. This role is accountable for their continuous compliance with regulations.Essential Functions of the Job (Key responsibilities)Develop and oversee the Digital Quality Management System governance model and roadmap that supports pre-clinical, clinical, manufacturing, distribution and Pharmacovigilance activities. Ensure alignment with the business needs and Quality Plan/StrategyAct as System owner of all digital GxP enterprise Quality applicationsEnsure the Digital QMS is maintained in accordance with current regulatory standards and meets corporate quality and business objectivesLeads e-systems developments and enhancements projects in collaboration with the network of Quality process owners and ITLeverage Artificial Intelligence capabilities to enhance our digital QMSDevelop and maintain digital Quality applications system administration processes, including business Continuity planningAssure Inspection readiness of digital Quality applications and be the Subject Matter Expert during Health Authorities Inspections on enterprise Quality applicationsSupport the identification of digital solutions addressing Quality business needsAct as QA lead for cross functional GxP digital applications projectsManage the business relationship with the suppliers of digital quality applicationsPromote a strong Quality culture to ensure Incyte digital applications implementation and usage is fit for intended use and ensures highest level of data integrity and complianceSupport the Global Quality leadership team in driving key Quality culture initiativesResponsible for developing and continuously improving core GxP and Quality training program, including strategy and delivery methods, fostering Incyte Culture of QualityDevelop new and innovative approaches to GxP and Quality TrainingsCollaborate with other GxP operational teams to develop a common framework for GxP trainingsCollaborate closely with IT, Quality and Operations teamsConduct Corporate Quality auditsQualifications (Minimal acceptable level of education, work experience, and competency)Advanced degree in life sciences, quality, or related field requiredMinimum 10 years in Quality Assurance in a Pharmaceutical / Medical Device Industry in an international environmentIn-depth operational experience in one area of the GxP allowing solid understanding of Business needs in terms of digital quality applicationsExcellent knowledge of US, EU, ICH GxP regulationsExperience in Managing and operating digital Quality applicationsStrong leadership, project management, and relationship building skillsAbility to communicate complex information effectively across functionsCertified quality auditorDisclaimer: 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.Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.We Respect Your PrivacyLearn more at: http://www.incyte.com/privacy-policyThe 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.