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IT Compliance Manager

2 months ago

Columbia, South Carolina, United States CARsgen Therapeutics Full time
About the Role

We are seeking a highly skilled IT Compliance Manager to join our team at CARsgen Therapeutics. As a key member of our organization, you will play a critical role in ensuring the integrity and compliance of our IT systems.

Key Responsibilities
  • System Implementation and Maintenance

Assist in the design, implementation, and maintenance of IT systems, including MES, LIMS, QMS, and DMS, to ensure they meet regulatory requirements and company standards.

Regulatory Compliance

Develop and maintain a deep understanding of FDA regulatory requirements, including data integrity and data governance, and ensure that our IT systems comply with these regulations.

Quality Management

Collaborate with the QA department to identify and mitigate quality risks associated with IT systems, and develop corrective actions to address any deviations or non-compliance issues.

Technical Support and Innovation

Provide technical expertise and support to ensure the smooth operation of IT systems, and drive innovation and optimization initiatives to improve system performance and efficiency.

Collaboration and Communication

Work closely with cross-functional teams, including business and technical departments, to ensure that IT systems meet business needs and regulatory requirements.

Requirements
  • Experience

5 years of experience in IT-related work, preferably in the pharmaceutical industry.

Regulatory Knowledge

Familiarity with FDA regulatory requirements, including data integrity and data governance, and experience with regulatory standards, such as CAPA and deviations.

Technical Skills

Knowledge of IT systems, including QMS, DMS, MES, LIMS, and WMS, and experience in implementation, validation, and operational maintenance.

Soft Skills

Ability to work in a global business environment, communicate effectively, and collaborate with cross-functional teams.