IT Quality Manager

3 weeks ago


New York, United States Tandym Group Full time

A medical organization is seeking an IT Quality Manager to join their team. In this role, the IT Quality Manager will be responsible for overseeing the development and maintenance of a robust quality management system within the Enterprise Information Technology department.

***This is a Remote opportunity, however the qualified professional needs to be able to go in office as needed (couple times a month). Offices based in NYC, Westchester County, NY, Rhode Island, Kansas City, Delaware, and Minnesota.***

Responsibilities:

The IT Quality Manager will:

  • Coordinate with Quality and other business partners concerning supplier, external, and/or internal audits
  • Conduct Failure Mode and Effect Analysis (FMEA) for new changes
  • Develop, implement, and maintain a comprehensive quality management system for Information Technology processes and services
  • Conduct regular audits to assess compliance with established quality standards and regulatory requirements
  • Identify opportunities for process improvement within the Information Technology department to enhance efficiency and effectiveness
  • Establish key performance indicators (KPIs) to measure and report on the quality of Information Technology services and processes
  • Generate regular reports for management, highlighting areas of improvement and success
  • Evaluate and ensure the quality of products and services provided by external vendors
  • Identify and assess risks related to Information Technology quality and develop risk mitigation strategies
  • Develop and deliver training programs to enhance the awareness and understanding of quality management principles among Information Technology staff
  • Ensure validation/ testing deliverables comply with change management procedures, especially in areas that follow good manufacturing practices
  • Acts as a liaison between end users and the Information Technology team to get an in-depth knowledge and understanding of the change in order to create requirements specification document
  • Perform other duties, as needed

Qualifications:

  • 5+ years of progressive software quality assurance and validation experience,
  • At least 5+ years of hands-on experience in a regulatory environment (such as FDA, AABB, FACT, and/or NY State)
  • Bachelor's Degree required in Quality Assurance, Operational Excellence, Information technology, or related discipline
  • Knowledge of industry standard quality assurance and continuous improvement methodologies to ensure Information Technology systems deliver the intended performance and ensure they meet regulatory requirements
  • Knowledge of cGMP, GXP regulations, including 21CFR part 11, and good documentation practices
  • Familiar with Azure Devops, creating deployment tests, error coding, logging errors, etc.
  • Experience in developing, consolidating, and implementing validation & testing strategy
  • Ability to plan and efficiently organize job tasks or resources
  • Ability to be responsive and available to management to address issues and concerns as they arise
  • Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to identify complex problems on time, decipher information to develop and evaluate options and implement solutions

Desired Skills:

  • Master's Degree
  • Certified Process Validation Professional from CfPIE, ASQ
  • Certifications or training in Quality Assurance, Operational Excellence, Total Quality Management, Continuous Improvement, and/or Lean/Six-Sigma

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