Associate Director, IT Compliance Applications

Role Summary

This role serves as the IT System Owner for the Learning Management System and compliance IT systems, including supporting GxP-regulated applications, while functioning as a strategic IT business partner for Compliance. The position requires a blend of technical expertise and business acumen to ensure regulatory compliance, system integrity, and alignment with business objectives across multiple IT platforms.

Responsibilities

• Act as strategic IT business partner for the Compliance department, serving as the primary IT liaison for their technology needs
• Serve as primary liaison between vendors and business for the supported systems
• Align IT initiatives with business strategy and priorities across all technology solutions
• Support business requirements gathering for system enhancements and new system implementations
• Provide ongoing IT support and consultation for business processes and technology needs
• Collaborate with business to identify technology opportunities and solutions that support business objectives
• Serve as the designated IT System Owner for the Learning Management System and compliance IT systems
• Drive compliance as IT system owner of the application, supporting internal and external audits to ensure regulatory compliance
• Manage technical ownership, change control, and documentation while ensuring system integrity and regulatory adherence throughout the system lifecycle
• Ensure systems meet business needs and operational requirements while being responsible for technical stability, system administration, and maintenance across the technology portfolio
• Maintain system changes, releases, and patches; review system releases and patches for impact across multiple systems
• Ensure that System Administration and Maintenance SOPs are created/updated as appropriate for all managed systems
• Oversee technical implementation, integration, and optimization of multiple systems, ensuring alignment with business objectives
• Collaborate closely with cross-functional teams including Quality Assurance, IT, CSV, and Compliance departments
• Ensure that Disaster Recovery meets the requirements of the business

Qualifications

• Required: Bachelor's degree in Computer Science, Information Technology, or related field
• Required: 7+ years of experience in IT with specific focus on Compliance-related systems
• Required: Technical knowledge of LMS applications, compliance business, and IT infrastructure
• Required: Previous experience managing computer systems in pharmaceutical environments
• Required: Knowledge of System Operational procedures and methodologies across various system types
• Required: Excellent leadership, communication, and problem-solving skills
• Required: Proven ability to serve as IT partner and manage multiple system portfolio
• Preferred: Experience with ComplianceWire/UL, Veeva Vault, and other similar software platforms
• Preferred: Knowledge of 21 CFR Part 11, Electronic Records and Electronic Signatures
• Preferred: Experience with GAMP 5 guidelines and validation lifecycle processes
• Preferred: IT System Project management
• Preferred: Experience managing vendor relationships for multiple software platforms

Education

• Bachelor's degree in Computer Science, Information Technology, or related field

Additional Requirements

• Up to 10% travel based on business need