Description

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. 

Roles & 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.

Education & Licenses and Experience

• 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. 

Competencies & Preferred Qualifications

• 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.

Why Join Us? 
 Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. 

Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. 

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