CSV QMS Specialist

Location Groningen
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Garreth Koslowski

Contact email: n.khan@panda-int.com
Job ref: 20230
Published: 25 days ago
For one of our key medical devices clients in Groningen, we are searching for a CSV QMS Specialist. In this position you will have accountability for the End-to-End of MAKE Technology Services for J&J MLL (Manufacturing, Logistics and Laboratory) the EMEA Surgical Vision sites.  This will entail delivery of Infrastructure Services and Application and platform Build (Development) and Run (Support) services, (including End User Services).

This includes managing the monitoring of application and platform performance, service health performance metrics, change management, development for projects and enhancements, ticketing and resolution of incidents, resolution of identified problems, execution of releases associated 

Responsibilities:
  • End-to-end IT risk management at the site including lifecycle management, information security, and GxP
  • Ensure IT uptime and operations reliability and IT services are delivered per SLA
  • Ensure incidents are followed up if/when needed for root cause investigation and preventative action
  • Collaborate with JJT Teams to deliver solutions and to manage escalations where needed for new demand or delays to committed dates on service requests.
  • Communications on updates, requested statistics and service level compliance
  • Training of team to site QMS and JJT QMS
  • Management of the contracted support and delivery teams to maximize value
  • Provide innovative ways of problem solving and implementing system improvements.
  • Ensure all applicable systems are validated by working with Quality Assurance and Regulatory Affairs departments and internal IT SME’s.
  • Partner with Product Line Owners to define and execute Service Lifecycle and roadmap and continuous Improvement Plans
  • End-to-End delivery of application and infrastructure Build and Run Services
  • Perform assessment, develop plan, and support models for all Manufacturing systems
  • Determine optimization opportunities and execute to result in reduced Total cost of ownership while maintain established Service Levels. Establish standard processes.
  • Manage extended, global, enterprise teams of internal and external professionals.
  • Participate in the business planning activities (budgets, projects and resource planning).  Interview, hire and manage outside contractors as required.
  • Execute Vendor optimization strategies and optimized support models
  • Ensure execution excellence in the delivery of I/T objectives and delivering. Ensure  IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, WICO, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.
  • Delivery on best practices and solutions to align to standards of the Shared Services organizations.

Your profile:
  • Minimum BS/BA in Computer Science or equivalent required
  • 10 years’ experience supporting Supply Chain/Manufacturing required
  • Expert experience in GxP systems, Computer System Validation and proven track record in the support of FDA regulated systems and business required
  • Experience in application development and support preferred
  • Training with certification (Green or Black Belt) in Process and/or Design Excellence preferred
  • Training in Process Mapping and Design preferred
  • Working knowledge of IT Service Management frameworks including but not limited to ITIL preferred
  • Proven track record in optimizing processes and delivering upon cost reduction challenges required
  • Expert communication skills required including at the executive level required
  • Understanding of Agile methodologies and DevOps concepts preferred.
  • English and Dutch speaking

Practicalities:
Location: Groningen and Eindhoven
On-site
Start date: ASAP
Duration: 12 months