Systems Support
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Systems Support
Ref No.: 18-00033
Location: Baltimore, Maryland
Start Date: 07/27/2018
 
IT Lead - Pharmaceutical/Biotech
Baltimore, MD, US
 
A growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service who provide process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing Client technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a team member, you will actively contribute to the delivery of our services and products to our customers and their patients.
The IT Lead will develop their skills with a fast-growing Biotech company.  This role will provide business user and systems support along with project execution for activities relating to the company's Cloud based Enterprise Resource Planning (ERP) and Quality Management Systems (QMS) platforms. This role will:
Key Responsibilities include but are not limited to:
  • Attain deep knowledge in the ERP and QMS modules, associated business process and points of integration with other applications.
  • Partner with the vendors and IT infrastructure support team regarding product roadmap, enhancement suggestions and support cases.
  • Ensure the integrity and security of information and access to support company reporting and internal control standards.
  • Enable application support for all users across the firm.
  • Lead projects such as platform installations, upgrades and migrations, and data extracts for financial or audit purposes.
  • Leverage change and release management process to ensure all platform updates and upgrades are thoroughly tested and signed-off prior to go-live.
  • Lead projects with operational leaders to drive Platform and business process improvements.
  • Continually enhance the user experience across the firm by using tools such as SharePoint, news feeds and hands-on training or knowledge sharing sessions.
  • Works with end-users to analyze, design, construct and implement small applications and/or solutions in support of regular business operations; documents applications and provides cross-functional training as needed.
  • Maintains liaisons with business, technical staff, and extended support organizations for resolution of ERP or QMS related issues.
  • Works with end users on all functional modules to document business needs/requirements for upgrades and enhancements.
Education & Experience:
Required: 
  • Bachelor degree in Information Technology, Science, Engineering or Business field
  • Proven record of successful vendor relationship management
  • Excellent understanding of cGMP's and System Development Life Cycle methodologies. 
  • Excellent facilitation, problem solving, and decision-making skills.
  • Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
  • Excellent written and oral communication skills.
  • Working knowledge of the regulatory requirements for pharmaceutical applications
  • Understanding of ITIL support methodologies.
  • Experience in supporting QMS and/or ERP platforms in a GxP environment.
 Preferred:
  • Proven facilitation, meeting/workshop management, project management and change management skills.
  • Experience in Process Data Analytics
  • Understanding and application of LEAN/MPS principles
  • Strong background in Sharepoint Architecture and capabilities.