Overview
The Senior Manager, Digital Quality Programs reports to the Associate Director Global QMS improvement within the corporate quality Management organization.
This role drives the digital QA roadmap and leads the implementation of digital and AI capabilities within Digital Quality platforms. Acting as the Veeva Quality System Owner across all GxPs, the Sr Manager ensures the platform evolves to meet patient, regulatory, and business needs. The role is accountable for strengthening data governance, and leading major cross functional digital initiatives while fostering Incyte’s Quality culture: Patients first, Quality always.
DUTIES AND RESPONSIBILITIES
* Develop and oversee the Digital Quality roadmap covering pre-clinical, clinical, manufacturing, distribution and Pharmacovigilance activities. Ensure alignment with the business needs and Quality Plan/Strategy
* Serve as System owner of digital Quality applications
* Identify and support the adoption of innovative digital solutions within QA, including new AI capabilities, to address evolving Quality business needs
* Maintain and improve the digital Veeva QMS governance model ensuring benefits and compliance requirements are appropriately assessed, prioritized and implemented
* Ensure the Veeva Digital QMS remains fit for purpose and aligned with current regulatory standards including periodic releases
* Lead system development and enhancement projects in collaboration with Quality process owners, business users and IT
* Oversee the Veeva Quality System administration and ensure appropriate business continuity planning is defined and maintained
* Assure Inspection readiness of the Veeva digital Quality applications and be the Subject Matter Expert during Health Authorities Inspections
* Manage large project initiatives related to digital systems and new AI capabilities across functional GxP
* Develop and maintain strong relationship with suppliers of the Veeva digital quality applications
* Contribute to promoting 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
* Collaborate with GxP operational teams, QA and IT to develop a common framework for the Veeva digital systems
* Drive the digital data governance strategy and ensure its appropriate and effective implementation
* Conduct Corporate Quality audits
REQUIREMENTS
* Advanced degree in life sciences, quality, or related field
* Minimum 7 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 and ICH GxP regulations
* Solid experience in managing and operating digital quality applications
* First successful experience with AI technology deployment
* Fluent in English and French
DISCLAMER
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.
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