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IT Compliance Manager

2 months ago

Columbia, South Carolina, United States CARsgen Therapeutics Full time

Key Responsibilities

  • Support the central IT team in the design and execution of information systems (MES, LIMS, QMS) at the facility.
  • Possess a solid understanding of GMP principles, manage associated risks during project execution, and formulate appropriate risk mitigation strategies.
  • Accountable for developing standard operating procedures, protocols, and compliance documentation for the IT division in alignment with FDA regulations.
  • Oversee the daily functioning, troubleshooting, and upkeep of GMP-related information systems to guarantee operational efficiency and data accuracy.
  • Engage in the testing, validation, and refinement processes of computerized systems prior to their deployment.
  • Work collaboratively with various departments, including business and quality assurance, to address quality incidents and deliver technical assistance.
  • Assist with system validation activities.
  • Offer insightful technical recommendations and solutions to enhance systems and workflows.
  • Promote technological advancements and system enhancements.
  • Collaborate with other technical teams, business units, and leadership to comprehend and fulfill the overall organizational requirements.

Required Qualifications

  • A minimum of 5 years of IT experience within the pharmaceutical sector.
  • In-depth knowledge of FDA regulations concerning data integrity and governance for computerized systems.
  • Familiarity with FDA compliance standards, with the ability to manage changes, deviations, CAPA (Corrective and Preventive Actions), and related tasks.
  • Capability to conduct GMP audits for both internal and external purposes, with familiarity in relevant processes and biopharmaceutical regulatory standards.
  • Expertise in QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) information systems, with hands-on experience in implementation, validation, and operational support.
  • Experience in managing and maintaining servers, networks, and computers, with technical proficiency in at least one area such as database administration, development, mainstream network engineering, or infrastructure. Strong communication skills in a global business context.