Incyte · 15 hours ago
Senior Manager, GxP Digital Systems Quality
Wilmington, DE
Full-time
Onsite
Senior LevelIncyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines. The Senior Manager, GxP Digital Systems Quality, is responsible for overseeing GxP IT systems quality and compliance activities, ensuring that regulated systems remain in a validated state and comply with relevant regulations.
BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
Responsibilities
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
Support the assessment of enterprise software systems to determine validation requirements and maintain accurate system inventories for regulated systems
Provide quality oversight for IT Computer System Validation (CSV) activities, ensuring validation deliverables meet global policies and procedures
Review and approve CSV documentation including Validation Plans, User and Regulatory Requirements, risk assessments, test evidence, Validation Summary Reports, and Change Controls
Provide SME support during Health Authority (HA) inspections on GxP computerized system related topics
Support IT Quality Management Review: Develop and maintain set of KPIs to monitor Digital activities and systems compliance
Perform Regulatory watch for digital activities
Process owner for Periodic Review of GxP systems - ensure that Periodic Review GxP applications are performed regularly as planned in accordance with SOP requirements
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
Lead and conduct IT vendor audits and assessments, including documentation review, on-site or remote audits, and follow-up activities
Monitor and maintain IT vendor qualification status, ensuring timely risk assessments, remediation, and re-qualification activities
Support inspection readiness and participate in regulatory inspections, internal audits, and partner audits as a subject matter expert
Provide quality review and approval of Deviations, CAPAs, Change Controls, and other IT-related quality events within the QMS
Ensure IT-specific QMS documents, processes, and records are aligned with and supported by Global QMS
Support QMS platform activities in collaboration with IT, including system enhancements, user access, and training
Drive and support data integrity initiatives including data audit trail reviews across IT systems, ensuring compliance with ALCOA+ principles
Act as a key quality partner to IT, Quality, and business stakeholders to ensure effective and compliant system implementations and changes
Promote consistent application of global IT quality processes and support the “one global process” philosophy
Identify opportunities for process improvement, standardization, and efficiency within IT GxP systems quality and CSV practices
Support the development, revision, and implementation of IT quality-related SOPs, policies, and work instructions
Manage multiple projects and priorities simultaneously in a fast-paced, regulated environment
Execute business process and system ownership responsibilities for assigned Quality-owned systems
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline, or equivalent practical experience
Significant experience in the pharmaceutical, biotechnology, or regulated life sciences industry with a focus on IT Quality and Computer System Validation
Hands-on experience supporting systems across the drug development lifecycle, from discovery through post-approval
Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and relevant global regulations and guidance
Solid understanding of data integrity principles and their application to IT systems
Experience with software development lifecycle (SDLC) methodologies in a regulated environment
Working knowledge of IT infrastructure, enterprise applications, and system architecture
Strong project management and organizational skills with the ability to manage competing priorities
Excellent written and verbal communication skills, with the ability to influence and collaborate effectively across functions and levels
Demonstrated ability to work in global and cross-cultural environments
Experience participating in or supporting regulatory inspections and audits
Preferred
Experience serving as a system or business process owner
Prior people-management or team-lead experience
Active participation in industry organizations (e.g., ISPE) is a plus
Company
Incyte
Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.
Founded in 1991
1001-5000 employees
H1B Sponsorship
Incyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-01-16IPO
Leadership Team
Bill Meury
President & CEO
Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
Recent News
2026-01-07
2026-01-06
Company data provided by crunchbase