At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

The Information Technology Quality Manager is responsible for:

• Oversight of the development and maintenance of a robust quality management system within the Enterprise Information Technology department,
• Gaining an understanding of Enterprise Information Technology operations, user needs to design user, functional, and design specifications to provide knowledge for internal interfaces by working with diverse end users across the company and will acquire an understanding of NYBCe systems and monitor changes in procedures to ensure system continuity, and
• Providing excellent communication skills in a fast-changing environment with strong attention to detail and serving as an ambassador for Quality in Information Technology.

This role involves ensuring compliance with:

• Industry standards (such as FDA, AABB, FACT, and/or NY State),
• Conducting audits,
• Driving continuous improvement initiatives, and
• Fostering a culture of quality.

The individual in this position will collaborate with various stakeholders, manage risk, and implement strategies to enhance overall Information Technology service quality.

The position supports Enterprise Information Technology quality efforts by accepting responsibility for:

• Initiating action to prevent the occurrence of any nonconformances relating to process and Information Technology systems,
• Identifying and recording any problems relating to the process and Information Technology system,
• Initiating, recommending, or providing solutions through designated channels,
• Verifying the implementation of solutions, and
• Controlling the further processing, delivery or installing of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
• Essential Functions
• Coordinates with Quality and other business partners concerning supplier, external, and/or internal audits.
• Conducts Failure Mode and Effect Analysis (FMEA) for new changes.
• Oversight of Root Cause Analysis for issues and/or deviations.
• Quality Management Systems:
  • Develop, implement, and maintain a comprehensive quality management system for Information Technology processes and services, and
  • Define quality standards and procedures aligned with industry best practices and organizational objectives.
• Audit and Compliance:
  • Conduct regular audits to assess compliance with established quality standards and regulatory requirements, and
  • Collaborate with internal and external stakeholders to address audit findings and implement corrective actions.
• Process Improvement:
  • Identify opportunities for process improvement within the Information Technology department to enhance efficiency and effectiveness, and
  • Collaborate with Information Technology teams to implement best practices and continuous improvement initiatives.
• Quality Metrics and Reporting:
  • Establish key performance indicators (KPIs) to measure and report on the quality of Information Technology services and processes, and
  • Generate regular reports for management, highlighting areas of improvement and success.
• Vendor Management:
  • Evaluate and ensure the quality of products and services provided by external vendors, and
  • Collaborate with procurement and vendor management teams to establish quality criteria for vendor selection and ongoing performance monitoring.
• Risk Management:
  • Identify and assess risks related to Information Technology quality and develop risk mitigation strategies, and
  • Work with the Information Technology teams to ensure that quality management practices align with cybersecurity requirements.
• Training and Awareness:
  • Develop and deliver training programs to enhance the awareness and understanding of quality management principles among Information Technology staff, and
  • Promote a culture of quality and continuous improvement throughout the Information Technology organization.
• Customer Satisfaction:
  • Monitor and measure customer satisfaction with Information Technology services, and
  • Implement initiatives to address customer feedback and improve overall satisfaction.
• Must be able to develop and/or revise SOPs & work instructions,
• 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, and
• Knowledge of cGMP, GXP regulations, including 21CFR part 11, and good documentation practices. As this position requires close customer interaction, excellent oral, written, and presentation skills are mandatory.

Education

• Bachelors Degree required in Quality Assurance, Operational Excellence, Information technology, or related discipline. Masters degree preferred,
• Proven experience in quality management within an Information Technology environment,
• Strong understanding of industry regulations and standards related to Information Technology quality, and
• Agile experience preferred.

Experience

• 5 years of progressive software quality assurance and validation experience,
• Knowledge of industry standard quality assurance and continuous improvement methodologies to ensure our Information Technology systems deliver the intended performance and ensure they meet regulatory requirements,
• Familiar with Azure Devops, creating deployment tests, error coding, logging errors,
• At least 5 years of hands-on experience in a regulatory environment (such as FDA, AABB, FACT, and/or NY State), and
• Experience in developing, consolidating, and implementing validation & testing strategy.

Licenses & Certifications

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

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $ 140,00.00 p/yr to $150,000.00 p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicants skills, job-related knowledge, and experience.