ZTD GMS Systems Lead & Business Partner

Role Description

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

The ZTD (Zoetis Technology & Digital, Information Technology) Solution Partner, Quality Systems will be the primary point of contact across Global Manufacturing & Supply (GMS) and Research and Development (RD) for global quality laboratory solutions .

The role includes system ownership and global deployment for Waters Empower Enterprise, Molecular Devices Softmax Pro GXP, and other laboratory systems operating within the Animal Health sciences industry.

Works closely with other global solution teams to interface with systems such as Waters SDMS laboratory data archival and Waters LMS electronic notebook.

The role requires knowledge, ability, and experience to operate and maintain software solutions in a regulated environment.

Due to the regulated environment, the position requires deploying and maintaining solutions that are subject to the rules and regulations of various global regulatory agencies such as FDA, USDA, and EMA to remain in compliance with regulations pertaining to software solution delivery and data integrity.

Key Responsibilities

• Provide / coordinate ongoing support for global laboratory system solutions.
• Be the primary point of contact to the business, compliance, and infrastructure teams for aforementioned quality systems.
• Develop / maintain all documentation relevant to operating software systems in a regulatory environment.
• Aid with issue and risk management efforts.
• Communicate to respective business units on all matters of relevance.
• Maintain and update software solutions as required to remain current with emerging technologies.
• Perform troubleshooting and 3rd level support for a variety of laboratory instrument types and vendors.
• Persistently focus on data integrity and compliance.
• Work closely with Managed Service Provider on Ticket Management.

Position Responsibilities

• Work within an established operating model for ZTD GMS Global Systems, overseeing the end-to-end Deploy, Enhance, and Run Operations for regulated laboratory solutions.
• System Ownership of global Empower chromatography solution which operates 24x7 and is deployed globally. Act as the primary point of contact between business and ZTD, providing L3 support for real-time product testing for manufacturing operations, and maintaining GxP documentation set following Zoetis Solution Delivery Life Cycle.
• System Ownership of global Softmax Pro GXP and other global laboratory solutions that operate 5x12 locally with similar ownership responsibilities.
• Support time-critical remediation activities, when necessary, in the event of global service interruptions, regulatory agency audit support, and solution upgrade or enhancement deployments.
• Evaluate and deploy future software and instrument control updates for support systems as needed.

Education and Experience

• University Degree in Computer Science / Information Systems / Business Administration or other relevant fields. MBA or Equivalent Degree Preferred.
• 10+ years of progressive technology experience in establishing requirements and design, deployment, operation, and maintenance of ZTD solutions operating in a regulated environment.
• Strong interpersonal, communication, and collaboration skills.
• Knowledge and experience working with laboratory solutions in a regulated environment, especially related to Chromatography and Laboratory Execution Systems such as Waters Empower or Waters LMS.

Technical Skills Requirements

• Microsoft Windows - Servers and Client Operating Systems, security tools, configuration for vendor-supplied solutions, maintenance activities.
• Knowledge and practical experience with Waters Corporation informatics solutions (Empower, NuGenesis, LMS).
• Practical experience working in Windows operating environment (client / server, lab PCs, laboratory instrumentation communications, general office and collaboration tools, software installation, PowerShell).
• Proven track record of delivering innovative and successful IT systems.
• Demonstrated ability to troubleshoot / resolve issues related to software solutions operating in a laboratory environment.
• Knowledge of system development methodologies and compliance requirements (e.g., SGMP, GxP, 21CFR).

Physical Position Requirements

Office-based activities. Minimal travel may be required related to laboratory system deployments, maintenance, and upgrades.

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