At New York Blood Center Enterprises (NYBCe), 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 Senior Director, IT Regulatory and Compliance is responsible for developing and implementing IT quality and compliance frameworks that adhere to regulatory standards, including FDA requirements, with a particular emphasis on regulated medical device development.

This role ensures IT systems, processes, and technologies comply with GDPR, HIPAA, FDA, and internal quality policies, focusing on quality assurance, controlled document oversight, technical writing, and validation.
By acting as a liaison between IT and the Quality team, the Senior Director aligns IT processes with quality and compliance objectives, enhancing collaboration and effectiveness across departments.

In this capacity, the Senior Director manages quality assurance programs, conducts audits, and maintains FDA-compliant IT processes to align IT initiatives with broader governance and risk management frameworks.

The Senior Director leads a dedicated team in IT quality, compliance, and risk management and fosters a culture of accountability and continuous improvement. This role is crucial in protecting the organization from regulatory and quality risks and ensuring validated, high-quality, and reliable IT systems that support medical device development and broader organizational objectives.

1. Develop and Oversee Quality Management Systems (QMS)

• Design and implement an IT QMS that ensures compliance with FDA, ISO, and other regulatory standards, particularly for regulated medical device development.
• Conduct regular quality audits and assessments, monitoring performance metrics and managing continuous improvement to optimize IT service delivery and system reliability.

2. Ensure Regulatory Compliance, Including FDA Requirements (Medical Device Development)

• Develop and enforce IT policies and procedures to ensure FDA compliance, covering medical device development and including cGMP, GxP, 21 CFR Part 11, and documentation practices.
•  Prepare for and manage compliance audits, including FDA-specific inspections, maintaining detailed documentation and ensuring corrective actions for non-compliance.

3. Act as Liaison Between IT and Quality Teams

• Serve as the primary connection between IT and Quality, ensuring alignment on compliance, quality, and documentation for regulated medical devices.
• Work closely with the Quality team to support product quality, data integrity, and regulatory standards across IT, facilitating cross-department collaboration.

4. Governance, Risk, and Compliance (GRC) Integration and Collaboration

• Partner with the GRC team to integrate IT compliance, quality, and risk management with the organization’s broader GRC strategy.
• Support the use of GRC tools for risk monitoring, compliance reporting, and incident management within IT, aligning processes with governance policies.

5. Risk Management and Incident Response

• Develop and maintain a risk management framework focused on compliance, quality, and FDA requirements, with a strong emphasis on data security and integrity.
• Manage incident response, conducting root-cause analysis and implementing corrective actions for compliance and quality-related issues.

6. Vendor and Third-Party Compliance Management

• Ensure that third-party vendors adhere to regulatory, quality, and FDA standards, including contractual obligations for controlled documentation and validation.
• Conduct vendor risk assessments and audits to align external partnerships with the organization’s GRC and quality frameworks.

7. Lead and Mentor the IT Compliance and Quality Team

• Build and guide a team focused on IT quality management, compliance, and risk mitigation, providing training on FDA and other regulatory requirements.
• Foster a culture of compliance, continuous improvement, and accountability within the IT department.

8. Monitor and Report on Compliance and Quality Performance

• Report to senior leadership on IT compliance, quality metrics, and FDA-related risk assessments, providing recommendations and corrective action plans.
• Establish transparent reporting processes for accountability in compliance, quality, and risk performance.

9. Drive Continuous Improvement in IT Compliance and Quality Processes

• Lead initiatives to enhance compliance, quality, and risk management through new technologies, including controlled documentation, technical writing, and validation practices.
• Stay informed on FDA and industry trends to adapt IT compliance and quality strategies, implementing workflows to increase efficiency and reduce risks.

Education:

• Bachelor’s Degree required in Quality Assurance, Operational Excellence, Medical Technology, Information technology, or related discipline.

Experience:

• 10+ years of progressive software quality assurance and validation experience,
• Proven experience in quality management within an Information Technology environment,
• 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.
• Agile experience is preferred.
• Strong understanding of industry regulations and standards related to Information Technology quality and
• Familiar with Azure DevOps, creating deployment tests, error coding, logging errors,

Knowledge & Skills:

• 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,
• Be eager to grow personally and professionally.
• Embrace accountability and ownership.
• Be willing to take on new challenges.
• Execute quickly – experiment and embrace learning from your failures.
• Build-in receiving feedback as part of the development process, seek consistent and constructive feedback.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $185,000.00p/yr. to $195,000.00p/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 applicant’s skills, job-related knowledge, and experience.

Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.