Associate Director, GxP Systems Application Management Services

The Role

In this role, you will lead and coordinate Application Management Services (AMS) for the Digital Quality GxP Systems within the CMC Digital Organization, supporting cGMP manufacturing and quality activities to ensure on-time and in-full deliveries. This role encompasses the responsibility to oversee all operational activities, ensuring they meet company standards and regulatory requirements, while driving continuous improvement and operational efficiency. The Associate Director will primarily focus on managing application services operations and support, working with cross-functional teams and Digital Quality Product Owners delivering upgrades, enhancements, new modules, and other systems development initiatives.

You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency.  You thrive in a fast-paced environment and are comfortable rolling up your sleeves – if a process doesn’t exist yet, you define it. You collaborate well amongst a team of expert peers and a cross functional quality operations userbase.

Here’s What You’ll Do

• Supervise Application Management Services (AMS) to ensure the Digital Quality Product ecosystem is effectively managed and remains GxP compliant.

• Develop, maintain, and continuously optimize Support and Service models for a variety of Digital Quality Products such as Veeva Docs/QMS, LabVantage LIMS, KNEAT, MODA EM-LIMS, Chromeleon Chromatography Data System, Benchtop Quality Control Instrumentation Systems, Automation Systems (Hamilton, Andrew+), etc.

• Accountable for problem resolution related to application issues across business units and regions; this includes working with Digital Quality Product Owners, business colleagues, business-facing IT colleagues, infrastructure teams, external partners, and/or vendors.

• Manage, oversee, and engage with external AMS Managed Service Providers (MSP) to ensure high-quality service delivery and adherence to SLAs.

• Oversee incident management, required escalations, and drive resolution for incidents impacting Digital Quality Products.

• Engage L3 technical/functional software support as required throughout product and project lifecycles.

• Proactively resolve service delivery, quality, process, resource, and performance issues by monitoring and analyzing usage data and metrics.

• Regularly report on performance, including status, issues, and risks, to leadership.

• Collaborate with Digital IT core support services and operations as required.

• Ensure Digital Quality Product owners maintain adherence to required periodic activities such as user reviews, backup/restore/disaster recovery challenges, patching cycles, periodic reviews, etc.; this includes optimizing the AMS team on delivery of these tasks and engaging related partners in the digital, business, and quality areas in collaboration on execution.

• Manage routine maintenance activity to ensure reliable and effective operation of the key platforms and services in the application portfolio.

• Support product owners in executing on Software Development Life Cycle (SDLC) management through routine systems health assessment, maintenance of high-quality documentation, and license management.

• Cultivate and maintain the informational IT knowledge-base containing documentation of applications, policies, procedures, infrastructure, and other critical technology assets.

• Ensure change management processes are continuously followed to maintain a stable production environment.

• Focus on quality and compliance within the manufacturing and operations areas.

• Use risk-based analysis to create and revise procedures to align with current regulatory requirements.

• Being a 24/7 global operation, work outside of core hours and on weekends may be required.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Basic Qualifications)

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

• Minimum of 12 years of experience in GxP systems management and digital operations.

• Proven experience in managing application services and working with external service providers.

• Strong understanding of cGMP manufacturing and quality assurance processes.

• Demonstrated ability to lead cross-functional teams and manage complex projects.

• Excellent problem-solving, organizational, and communication skills.

• Experience working with Digital systems hosted in cloud and understanding of