HTI has an immediate opening for an experienced Quality Systems IT Manager for a large pharmaceutical manufacturer in Greenville, SC. This is a full-time, salaried, onsite position. Relocation assistance is available. Salary depends on experience and education, and the range is approximately $85,000 - $102,000 / year.
Job Summary:
This position is a Computer Systems Engineer/Quality IT Systems Manager that possesses knowledge of software platforms, focused primarily on Salesforce and other hosted system platforms. The position will work with internal managers and software vendors to ensure that quality-centric applications function in line with business expectations. This position will resolve technical workflow issues, update coding within the systems, evaluate new software systems for business needs, update current workflows or metadata to address information needs, and implement ne
l-time/onsite (not remote) role.
Requirements:

• Bachelor's degree in Information Technology or Computer Science.
• Must have 4 years of quality systems management experience with Salesforce platform(s).
• Experience in a similar role within the pharmaceutical manufacturing industry strongly preferred.
• 3 years of CSV (Computer System Validation) and experience with TWD (TrackWise Digital), Blue Mountain, Compliance Wire, and eInfotree applications are strongly preferred.
• Experience should include configuration, validation, implementation, and/or system administration.
• Understanding of Pharmaceutical Quality requirements as they apply to a regulated pharmaceutical environment (cGMP, FDA).
• Strong written and verbal communication skills.
• Leadership/management experience strongly preferred.
• Ability to work independently or in a team environment.
• Demonstrated successful implementation of at least one similar or larger scale computer system.
• Demonstrated cost savings, process improvements or revenue enhancements for a hosted or salesforce platform system

• Strong Microsoft skill set, to include documentation formatting, Adobe application and Signature workflow process.
• Must be authorized to work in the U.S.

Job Duties:

• Evaluate new software applications for business needs.
• Maintain user licenses, contracts and system upgrades via change control system.
• Evaluate software applications in a test environment with system owners to ensure business requirements are met.
• Provide training on software workflows to employees.
• Update current workflows in systems as required for new information, or to simplify process, in a timely manner.
• Build new programs in the TrackWise application to meet business needs.
• Upgrade and/or update workflow processes in Blue Mountain, TrackWise, eInfotree, and Compliance Wire to meet regulatory requirements.
• Administer the day-to-day administrative needs of the systems.
• Maintain procedures for system administrators and update as needed.
• Maintain the uptime of the system.
• Provide a roadmap of system versions.
• Direct user administration of the system.
• Will manage one Quality Systems IT Technician.
• Manage the following:
  • New releases and fixes via change controls
  • User Requirement Specifications
  • Design Specifications
  • IQ/OQ testing
  • Requirements Traceability Matrices
  • Communicates design and workflow changes to internal employees
• Collaborate with Validation team and software vendors on:
  • System Description
  • Validation Plan
  • Data Migration Plan
  • UAT
  • Validation Summary Report
  • Decomissioning Plans
  • Periodic Reviews

EEO Employer / Veteran / Disabled.
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