Sr. Director - IT Applications

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Director of IT is responsible for the strategic leadership, delivery, and operational excellence of enterprise systems supporting Quality Management Systems (QMS), Regulatory & Compliance platforms, Product Lifecycle Management (PLM), and Application Management & Operations (AMO). Quality, Regulatory & Product Systems.

The role balances strategy, governance, and hands-on execution, while ensuring systems meet global regulatory requirements and operate with high availability, security, and performance.

Key Responsibilities

IT Strategy & Leadership

• Define and execute the IT roadmap for QMS, Regulatory, PLM, and supporting enterprise platforms aligned with business and compliance objectives.
• Provide leadership to internal IT teams and external partners, fostering accountability, continuous improvement, and operational excellence.
• Act as a trusted technology advisor to Quality, Regulatory, R&D, and Operations leadership.

Quality Management Systems (QMS)

• Own IT accountability for QMS platforms supporting CAPA, Deviations, Complaints, Change Control, Audit Management, and Document Control.
• Ensure systems are compliant with applicable regulations and standards (e.g., FDA, ISO, GxP, 21 CFR Part 11, Annex 11 where applicable).
• Partner with Quality teams to drive standardization, process maturity, and system adoption globally.

Regulatory & Compliance Systems

• Lead IT ownership of regulatory systems supporting submissions, registrations, labeling, and compliance tracking.
• Ensure system validation, data integrity, audit readiness, and inspection support capabilities.
• Manage regulatory system upgrades and enhancements with minimal disruption to compliance or business operations.

Product Lifecycle Management (PLM)

• Oversee PLM platforms enabling product data management, design control, BOMs, change management, and traceability.
• Integrate PLM with ERP, Manufacturing, Quality, and other enterprise systems to enable end-to-end digital product lifecycle visibility.
• Drive simplification and harmonization of product data and processes across regions and product lines.

Application Management & Operations (AMO)

• Lead AMO services for supported platforms, ensuring high availability, predictable performance, and strong service-level outcomes.
• Establish and monitor KPIs for incident management, problem management, change management, and release stability.
• Drive continuous improvement through automation, optimization, and reduction of technical debt.

Governance, Risk & Compliance

• Ensure all systems follow IT governance, validation, cybersecurity, and data privacy standards.
• Support audits and inspections by providing system evidence, documentation, and technical expertise.
• Manage vendor relationships, contracts, and service delivery performance.

Financial & Delivery Management

• Own budget planning, forecasting, and cost optimization for the application portfolio.
• Oversee large-scale programs, system implementations, and upgrades using disciplined delivery and change management practices.

REQUIRED SKILLS & MINIMUM QUALIFICATIONS

• Bachelor’s degree in information technology, Engineering, or a related discipline required; Master’s degree is highly desirable.
• Minimum of 15 years progressive IT experience; with minimum 5 plus years of experience as a Director or Sr. Director in Life science / Healthcare industry. 
• Extensive background in overseeing enterprise applications preferably QMS, Regulatory Systems, and PLM platforms within global enterprise settings.
• Comprehensive knowledge of regulatory compliance, system validation, and audit preparedness.
• Proven ability to manage GCC and/or AMO models, coordinate vendors, and lead global support teams effectively.
• A collaborative leader with a business-focused approach, adept at translating business and compliance requirements into robust, scalable technology solutions.

• Strategic thinker demonstrating strong execution discipline and a thorough understanding of quality, compliance, and risk management.

Additional Information:
This is a hybrid role, and the ideal candidate wil