Digital Quality Management Systems Director

3 hours ago

Wilmington, Delaware, United States Incyte Full time
Job Summary

The Director to Sr. Director, Digital Quality Management Systems (QMS) programs leads the digitalization of the Quality Management System at Incyte, a biopharmaceutical company focused on discovering, developing, and commercializing novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.

This role is accountable for ensuring the continuous compliance with regulations and overseeing the electronic enterprise Quality applications across the GxPs, ensuring their evolution to best serve the patients and business needs.

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/Strategy.
  • Act as System owner of all digital GxP enterprise Quality applications.
  • Ensure the Digital QMS is maintained in accordance with current regulatory standards and meets corporate quality and business objectives.
  • Leads e-systems developments and enhancements projects in collaboration with the network of Quality process owners and IT.
  • Leverage Artificial Intelligence capabilities to enhance our digital QMS.
  • Develop and maintain digital Quality applications system administration processes, including business Continuity planning.
  • Assure Inspection readiness of digital Quality applications and be the Subject Matter Expert during Health Authorities Inspections on enterprise Quality applications.
  • Support the identification of digital solutions addressing Quality business needs.
  • Act as QA lead for cross-functional GxP digital applications projects.
  • Manage the business relationship with the suppliers of digital quality applications.
  • Promote 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 compliance.
  • Support the Global Quality leadership team in driving key Quality culture initiatives.
  • Responsible for developing and continuously improving core GxP and Quality training program, including strategy and delivery methods, fostering Incyte Culture of Quality.
  • Develop new and innovative approaches to GxP and Quality Trainings.
  • Collaborate with other GxP operational teams to develop a common framework for GxP trainings.
  • Collaborate closely with IT, Quality, and Operations teams.
  • Conduct Corporate Quality audits.
Qualifications
  • Advanced degree in life sciences, quality, or related field required.
  • Minimum 10 years in Quality Assurance in a Pharmaceutical / Medical Device Industry in an international environment.
  • In-depth operational experience in one area of the GxP allowing solid understanding of Business needs in terms of digital quality applications.
  • Excellent knowledge of US, EU, ICH GxP regulations.
  • Experience in Managing and operating digital Quality applications.
  • Strong leadership, project management, and relationship building skills.
  • Ability to communicate complex information effectively across functions.
  • Certified quality auditor.

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