New York Blood Center · 1 day ago
Director - Quality and Regulatory Compliance CCS (Comprehensive Cell Solutions) – Rye, NY
Rye, NY
Full-time
Onsite
Director/Executive
$165K/yr - $175K/yr
10+ years expNew York Blood Center is a leading nonprofit blood center that has been providing lifesaving research and innovation for over 60 years. They are seeking a Director of Quality and Regulatory Compliance to lead initiatives in quality and compliance for their Comprehensive Cell Solutions business unit, ensuring adherence to regulatory standards and overseeing quality systems.
Health CareMedicalTest and Measurement
Responsibilities
Protect the safety of patients and HCT/P donors by advising subordinates as needed and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services
Report to top management on the performance of the quality system and any need for improvement
Identify regulatory risks, communicate them to management, and facilitate the development of mitigation strategies as appropriate
Oversee quality monitoring and improvement programs within CCS, while ensuring the organization's compliance with internal and external requirements
Lead CCS quality improvement projects dealing with broad or complex issues, or with strategic impact
Manage relationships with supplier and customer counterparts from a quality and regulatory point of view to support Operations. Ensure quality expectations are defined and agreed upon, including review of contracts and authoring of Quality Agreements
Review, author, and/or approve key CCS Quality Management System documents including SOPs, deviations, change controls, and complaints
Serve as a representative to accrediting and regulatory bodies. Serve as a key point of contact for managing and directing regulatory and accreditation inspections
Advise CCS clients as requested regarding operational and regulatory submission pathways and content. Participate in preparation of CMC submissions
Identify, engage, and collaborate with regulatory experts and consultants as needed
Collaborate with CCS quality and operations management to define and implement organizational goals and action plans
Drive a collaborative work environment that focuses on creating and maintaining a strong quality and continuous improvement culture within the organization
Identify and develop staff talent through mentoring, education, and broadened experience opportunities to ensure a high-performance workforce capable of delivering high quality services responsive to the needs to the organization
Supervise staff, including work assignments, performance review, time and attendance, and training
Participate in customer focus and engagement activities as assigned
Any related duties as assigned
Qualification
Required
Bachelor's Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management
Ten years of combined experience in quality management and regulatory affairs related to cGMP manufacturing, clinical trial manufacturing, and / or cellular therapies
Minimum five years of experience in a quality leadership role overseeing quality in a biologics, vaccine, or aseptic manufacturing environment
Preferred
Master's degree or higher preferred
Experience providing quality management oversight in a cell therapy manufacturing environment strongly preferred
Company
New York Blood Center
New York Blood Center is a blood collection and distribution organization.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Christopher D. Hillyer, MD
President & CEO, and Chief Scientific Officer
Adrian David
SVP and Chief Operating Officer, Blood and Laboratory Operations
Recent News
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