Associate Director, IT Applications - QRLS

Associate Director, IT QRLS (Quality, Regulatory, & Laboratory Systems)

The Director of Global QRLS leads the strategic direction and operational excellence of our IT Quality, Regulatory & Laboratory Systems function worldwide, with a focus on the USA, EU, and MENA regions. This pivotal role drives innovation, ensures compliance, and optimizes performance across all QRLS processes and services.

Key responsibilities include spearheading global initiatives, fostering cross-regional collaboration, and leveraging cutting-edge technologies to enhance Quality, Regulatory, and Laboratory processes. The Director will build strategic partnerships, drive business alignment, and cultivate a culture of innovation to maintain our competitive edge in QRLS capabilities across all regions. This role requires expertise in key systems such as the Veeva Suite (QualityDocs, QMS, RIM), Labware, Empower, Lab Equipment, and Lorenz to effectively manage and optimize our global QRLS solutions.

• Develop and execute a visionary global strategy for QRLS, driving innovation and operational excellence across regions.
• Lead end-to-end management of global QRLS operations, ensuring seamless alignment and performance across USA, EU, and MENA.
• Oversee budget allocation, project prioritization, and delivery for all global QRLS initiatives, optimizing resource utilization and ROI.
• Spearhead the implementation and optimization of state-of-the-art IS technologies and methodologies, including Veeva Suite (QualityDocs, QMS, RIM), Labware, Empower, and Lorenz, to enhance efficiency and effectiveness of business processes.
• Foster a culture of innovation and continuous improvement, driving competitive advantage through advanced QRLS capabilities and leveraging expertise in key systems.
• Orchestrate global support operations for QRLS, ensuring consistent, high-quality service delivery across all regions.
• Cultivate strategic partnerships with global business functions, aligning IT solutions with diverse regional needs and goals.
• Lead talent management initiatives, developing a high-performing, diverse global team through mentorship, succession planning, and professional growth opportunities.
• Ensure proactive compliance with evolving regulatory requirements across all operational regions.
• Champion change management and digital transformation initiatives within the QRLS domain, with a focus on maximizing the potential of our core systems like Veeva, Labware, Empower, and Lorenz.

Internal

• Global functional heads and leaders in Quality, Regulatory, and R&D across all regions
• C-suite executives and senior stakeholders in global business units
• Regional IT teams and cross-functional project teams

External:

• Regulatory authorities and industry bodies across different regions
• Strategic technology partners and vendors, including Veeva, Labware, Waters (Empower), and Lorenz
• Thought leaders and professional networks in QRLS and IT innovation, particularly those focused on quality management, regulatory information management, and laboratory information systems

QUALIFICATIONS

• Minimum:BS/BA degree in Computer Science, Information Systems or related field
• Preferred:

EXPERIENCE

• Minimum:Extensive senior leadership experience in global IT roles, with a proven track record in QRLS functions and hands-on experience with key systems such as Veeva Suite, Labware, Empower, Lorenz, and Lab Equipment integration.

• Preferred: 10+ years of progressive leadership experience in multinational IT environments, with significant exposure to Quality, Regulatory, and Laboratory systems, including deep expertise in implementing and managing Veeva Suite (QualityDocs, QMS, RIM), Labware LIMS, Waters Empower, and Lorenz docuBridge

SKILLS

• Visionary leadership with the ability to translate complex technical concepts into strategic business value
• Deep expertise in Quality, Regulatory, and Laboratory systems, including cutting-edge technologies and equipment, with specific proficiency in Veeva Suite, Labware, Empower, and Lorenz systems
• Proven ability to navigate complex regulatory landscapes and drive compliance across diverse global markets using regulatory information management systems like Veeva RIM and Lorenz docuBridge
• Excellence in large-scale project management and budget optimization in a global context, particularly in implementing and maintaining QRLS systems
• Outstanding stakeholder management skills, with the ability to influence and collaborate at all organizational levels
• Strong change management capabilities, driving digital transformation in complex, multi-regional environments, especially in the context of QRLS system implementations and upgrades
• Exceptional analytical and problem-solving skills, particularly in addressing QRLS challenges and optimizing system performance
• Demonstrated ability to build and lead high-performing, culturally diverse teams across multiple time zones
• Strong business acumen with the ability to align IT strategies with overarching business objectives, leveraging the full potential of our QRLS systems
• Excellent communication skills, adept at presenting complex technical information about QRLS systems to varied audiences