Senior Manager, GxP Digital Systems Quality

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 Senior Manager, GxP Digital Systems Quality, is responsible for the operational execution and oversight of GxP IT systems quality and compliance activities across the enterprise. This role ensures that regulated IT infrastructure, software systems and Artificial Intelligence (AI) technologies are maintained in a validated and inspection-ready state in compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable global regulations and industry standards.
Reporting to the Associate Director, this position serves as a key quality partner to IT and business stakeholders, providing hands-on leadership for Computer System Validation (CSV), IT vendor qualification, data integrity, and QMS-related activities. The Senior Manager drives consistent application of global processes, supports audits and inspections, and leads continuous improvement initiatives to enable efficient, scalable, and compliant IT systems.

Essential Functions of the Job (Key responsibilities)
 GxP IT Systems Quality & Compliance:
o Execute and oversee day-to-day GxP IT systems quality activities to ensure ongoing compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and other applicable global regulations.
o Support the assessment of enterprise software systems to determine validation requirements and maintain accurate system inventories for regulated systems.
o Provide quality oversight for IT Computer System Validation (CSV) activities, ensuring validation deliverables meet global policies and procedures.
o Review and approve CSV documentation including Validation Plans, User and Regulatory Requirements, risk assessments, test evidence, Validation Summary Reports, and Change Controls.
 Quality Culture and system compliance:
o Provide SME support during Health Authority (HA) inspections on GxP computerized system related topics
o Support IT Quality Management Review: Develop and maintain set of KPIs to monitor Digital activities and systems compliance
o Perform Regulatory watch for digital activities
o Process owner for Periodic Review of GxP systems – ensure that Periodic Review GxP applications are performed regularly as planned in accordance with SOP requirements
 GxP AI technologies Quality oversight :
o Provides QA oversight of GxP AI agents and AI-enabled systems, including risk-based validation approaches, lifecycle controls, data integrity, and alignment with FDA and EMA guidance for AI/ML technologies.
 Vendor Qualification & Audits:
o Lead and conduct IT vendor audits and assessments, including documentation review, on-site or remote audits, and follow-up activities.
o Monitor and maintain IT vendor qualification status, ensuring timely risk assessments, remediation, and re-qualification activities.
o Support inspection readiness and participate in regulatory inspections, internal audits, and partner audits as a subject matter expert.
 Quality Management System (QMS) & Data Integrity:
o Provide quality review and approval of Deviations, CAPAs, Change Controls, and other IT-related quality events within the QMS.
o Ensure IT-specific QMS documents, processes, and records are aligned with and supported by Global QMS.
o Support QMS platform activities in collaboration with IT, including system enhancements, user access, and training.
o Drive and support data integrity initiatives including data audit trail reviews across IT systems, ensuring compliance with ALCOA+ principles.
 Leadership, Collaboration & Continuous Improvement:
o Act as a key quality partner to IT, Quality, and business stakeholders to ensure effective and compliant system implementations and changes.
o Promote consistent application of global IT quality processes and support the “one global process” philosophy.
o Identify opportunities for process improvement, standardization, and efficiency within IT GxP systems quality and CSV practices.
o Support the development, revision, and implementation of IT quality-related SOPs, policies, and work instructions.
 People & Project Leadership:
o Manage multiple projects and priorities simultaneously in a fast-paced, regulated environment.
o Execute business process and system ownership responsibilities for assigned Quality-owned systems.
o Perform other duties as assigned.

Qualifications (Minimal acceptable level of education, work experience, and competency)
Education & Experience
o Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline, or equivalent practical experience.
o Significant experience in the pharmaceutical, biotechnology, or regulated life sciences industry with a focus on IT Quality and Computer System Validation.
o Hands-on experience supporting systems across the drug development lifecycle, from discovery through post-approval.
 Technical & Regulatory Expertise
o Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and relevant global regulations and guidance.
o Solid understanding of data integrity principles and their application to IT systems.
o Experience with software development lifecycle (SDLC) methodologies in a regulated environment.
o Working knowledge of IT infrastructure, enterprise applications, and system architecture.
 Skills & Competencies
o Strong project management and organizational skills with the ability to manage competing priorities.
o Excellent written and verbal communication skills, with the ability to influence and collaborate effectively across functions and levels.
o Demonstrated ability to work in global and cross-cultural environments.
o Experience participating in or supporting regulatory inspections and audits.
 Preferred
o Experience serving as a system or business process owner.
o Prior people-management or team-lead experience.
 Active participation in industry organizations (e.g., ISPE) is a plus

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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