Associate Director, IT Applications - Run

Role Summary

The Associate Director of the IT Application Run Team will be responsible for leading and managing within assigned areas, ensure the stability, compliance, and performance of enterprise applications. Ensuring that operational processes and computerized systems deployed across IOPS meet the needs of the business and are compliant with relevant regulatory and security standards. Works with the equivalent Run Application Leads at other sites ensuring global alignment.

Responsibilities

• Oversee day-to-day IT application operations to ensure high service levels and SLAs are met (coverage may include application administration, minor enhancements, user support, application lifecycle, and system monitoring).
• Manage allocation of resources to support and maintain current applications.
• Establish and manage indicators of system health and performance.
• Ensure changes to applications and platform/OS updates are managed appropriately in collaboration with IOPS IT Operations and Corporate IT.
• Oversee third-party service providers (e.g., MSPs), ensuring performance and cost-effectiveness in partnership with other IT Run leads.
• Assist in annual IT budgeting, vendor negotiations, and resource allocation.
• Create and develop metrics with team leaders and utilize MDI structures to ensure optimal process and service performance.
• Maintain responsibility for system documentation ensuring accuracy and currency. Conduct risk assessments, audits, and implement disaster recovery and business continuity plans.
• Prepare the teams for regulatory and internal audits.
• Work with the validation and DI function to ensure systems remain in a compliant state.
• Proactively work with System Owners and end-users to ensure high levels of customer satisfaction.
• Establish communication forums with upper management and customers to provide ongoing and prompt status updates.
• Drive a continuous improvement mindset. Introduce process improvements and automation initiatives
• Ensure employee training requirements are met, development plans are in place, and performance management processes are adhered to.

Qualifications

• Required: BS/BA in Information Technology or related field; 10+ years of industry experience in Information Systems and Technology or an equivalent combination of education and experience; 8 years managing employees and budgets; 7+ years in a GMP manufacturing environment and experience in a biotech/pharma environment.
• Preferred: Experience with IT Compliance guidelines including PICS, CFR21 Part 11, Annex 11 and GAMP.

Skills

• Leadership and people development
• Resource, budget, and vendor management
• Cross-functional collaboration and stakeholder engagement
• Process improvement and automation initiation
• IT compliance and regulatory awareness (PICS, CFR21 Part 11, Annex 11, GAMP)
• Operational management with strategic planning balance
• Change management and risk assessment
• Disaster recovery and business continuity planning
• Documentation and audits coordination