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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) · 1 day ago

Senior Manager, GxP IT Systems

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$150K/yr - $160K/yr

10+ years exp

Arcutis Biotherapeutics, Inc. is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. The Senior Manager, GxP IT Systems is responsible for the end-to-end lifecycle management and system ownership of GxP IT systems, ensuring governance, compliance, and effective implementation across various functions.

BiopharmaBiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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 decommissioning 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

Qualification

GxP complianceComputer System Validation (CSV)GAMP 5Change managementVendor managementData governanceAnalytical thinkingEffective staff managementPMP certificationQuality Management Systems (QMS)Electronic Document Management Systems (EDMS)Cross-functional collaborationCommunication skills

Required

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

Preferred

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

Certifications such as PMP or GAMP are a plus

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