Role Summary
The Associate Director of the IT Application Run Team leads and manages within assigned areas to ensure the stability, compliance, and performance of enterprise applications. Responsible for ensuring operational processes and computerized systems deployed across IOPS meet business needs and regulatory and security standards, and for coordinating with Run Application Leads at other sites to achieve 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 and 10+ years of industry experience in Information Systems and Technology or an equivalent combination of education and experience.
- 8 years of experience in managing employees and budgets.
- 7+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment.
- Experience with IT compliance guidelines including PICS, CFR 21 Part 11, Annex 11, and GAMP is preferred.
Skills
- Leadership and team development; ability to manage resources, budgets, and vendor relationships.
- Operational excellence and compliance focus; stakeholder engagement across levels.
- Process improvement and automation initiative identification and implementation.
- Strong understanding of IT compliance guidelines (PICS, CFR 21 Part 11, Annex 11, GAMP).
- Strategic planning balanced with hands-on operational management.
- Effective communication with upper management and customers; disaster recovery and business continuity planning.
Education
- BS/BA in Information Technology or related field.