Senior Manager, GxP IT Systems

Arcutis Biotherapeutics

About The Position

The Senior Manager, GxP IT Systems is responsible for the end-to-end lifecycle management and system ownership of Arcutis’ GxP IT systems. This role ensures governance and compliance, drives strategic initiatives, and ensures robust vendor and supplier management. Through cross-functional leadership, the Senior Manager partners with Business Process Owners, Quality, R&D, and other functions to deliver effective implementation, change management, operational excellence and inspection readiness of GxP IT systems. Critically, this role ensures adherence to regulatory requirements and internal SOPs for computerized systems.

Requirements

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
10+ years of experience in IT systems within a pharmaceutical/biotech environment, with at least 5 years in GxP compliance roles.
Change management and process optimization.
Cross-functional collaboration and stakeholder engagement.
Vendor and contract management.
Effective staff management.
Data governance, compliance, and risk management.
Analytical thinking and problem-solving.
Results-oriented mindset and continuous improvement focus.
Ability to influence without authority and foster a culture of compliance.
Deep expertise in GxP regulations and guidelines (FDA, EMA, ICH).
Proven experience with Computer System Validation (CSV), Computer Software Assurance (CSA), and GAMP 5.
Strong background in systems implementation and management, e.g. Quality Management Systems (QMS) and Electronic Document Management Systems (EDMS). Preferred experience with Veeva applications.
Demonstrated success leading cross-functional teams and system implementations.
Strategic thinker with strong business acumen and technical proficiency.
Excellent verbal and written communication skills.

Nice To Haves

Certifications such as PMP or GAMP are a plus.

Responsibilities

Ensure compliance with Arcutis’ GxP SOPs and global regulations
Oversee Computer System Validation (CSV) activities, including protocol development (IQ/OQ/PQ), risk assessments, and validation execution & documentation.
Ensure robust change control, including ownership and management of GxP IT system change controls, ensuring all activities are properly documented and compliant.
Manage, create, follow, and maintain IT Standard Operating Procedures (SOPs) for GxP IT systems, ensuring processes are current and meet regulatory requirements.
Maintain adherence to GAMP 5 and ALCOA+ principles for data integrity and system lifecycle management.
Ensure timely periodic reviews and audit trail monitoring for all GxP IT systems.
Serve as the IT System Owner for key GxP IT systems.
Manage deployment, monitoring, maintenance, upgrades and decomissioning of GxP IT systems.
Partner with Business Process Owners, Quality, R&D, and IT teams to implement, validate, and support GxP IT systems.
Lead investigations for GxP IT system deviations/incidents and manage CAPA implementation.
Support internal and external audits, ensure inspection readiness and timely resolution of findings.
Foster a quality culture of continuous improvement and compliance across teams.
Qualify and manage GxP IT system service providers per SOP and policies.
Coordinate with vendors for compliance verification and system enhancements.
Direct, develop, and oversee external consultants engaged in GxP IT system projects.
Drive process optimization initiatives and benchmark emerging technologies to enhance compliance and efficiency.
Maintain systems maintenance & upgrade schedule, assign resource, and track activities to completion; accountable for on time delivery of system changes, upgrades, patches.