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Global Quality Systems SME

  1. North America, United States
Michigan
  1. Permanent
Competitive
  1. Compliance / Quality Assurance
36818
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Global Quality Systems SME - Michigan, United Kingdom - Permanent

Are you local to Michigan and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Global Quality Systems SME to join their newly assembled team and help contribute towards the development of their next core projects.  

Responsibilities:
  • Work within an establish operating model for GMS Global Systems, overseeing the end to end Deploy, Enhance and Run Operations for regulated laboratory solutions.  This includes working with site based colleagues, 3rd party solution providers, laboratory personnel, designated MSP’s or other support teams, site Quality and VMRD laboratory personnel.
  • System Ownership of global Empower chromatography solution which operates 24x7 and is deployed globally.  Primary point of contact between business and, L3 support for realtime product testing for manufacturing operations, maintain GxP documentation set follow Solution Delivery Life Cycle
  • System Ownership of global Softmax Pro GXP and other global laboratory solutions that operate 5x12 locally with same ownership responsibilities mentioned above.
  • Support of time critical remediation activities when necessary in the event of global service interruptions (eg., Crowdstrike June 2024), regulatory agency audit support, and solution upgrade or enhancement deployments.
  • Evaluate and deploy future software and instrument control updates for support systems as needed to stay current on supported operating systems, Oracle and SQL databases, and backend tools such as Citrix and interfaced solutions.
  • Support and coordinates site based personnel around the globe as necessary to deploy new instrumentation software, solution application upgrades, troubleshooting, and small team of direct reports supporting the solutions. 
  • Works closely with Managed Service Providers to oversee L1/L2 support activities.
  • Merger and Acquisition support for new sites and/or site divesture as needed.  Manage projects to deploy supported solutions at new locations including the full range of project management activities related to such deployments. 
  • Manage resources, timelines, and task delivery for the teams comprised of GMS quality, manufacturing, andVMRD, infrastructure, site servers, and database teams, and vendor assigned deliverables.
  • Partner with key stakeholders on annual operating plans related to new initiatives and maintaining existing solutions including identifying required resources, financial needs, and project timelines.
  • Administrative duties to include maintaining currency on all compliance and required training curiculla.  Participate on cross-functional laboratory and change review boards, adherence to core principals, partner with Digital Data & Analytics teams.
Requirements:
  • Extensive technology experience in establishing requirements and design, deployment, operation, and maintaince of solutions operating in a regulated environment.
  • Strong interpersonal, communication, and collaboration skills.  Strategically acting as the System Owner and Business Partner primarily with Global Quality and site Quality and VMRD laboratories.  Works closely with functions including Application Hosting, Database Administrators, Global Service Desk, Site Leads, 3rd party software and instrument providers, Compliance, and the Project Management Office to plan, define, execute, and operate new solutions and enhanced system capabilities.
  • Knowledge and experience working with laboratory solutions in a regulated environment, especially as related to Chromatography and Laboratory Execustion Systems such as Waters Empower or Waters LMS. 
If this role is of interest to you, please apply now!
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