At New York Blood Center, our greatest strength is our people—the employees, blood donors and recipients, supporters, partners, and many others who join forces to save lives each and every day. As one of the most comprehensive blood centers in the world, we are driven by a passionate enthusiasm to strengthen our diverse communities, and we continue to build on a legacy of innovation that spans more than five decades. NYBC serves as a multifaceted, patient-focused healthcare resource and global change agent dedicated to improving public health, empowering communities, and maximizing resources through collaboration and partnership.
This position is responsible for ensuring the quality and safety of NYBC products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment and continuous improvement of work processes. The Manager implements and maintains the quality management system and ensures regulatory and accreditation compliance across several program areas, including cellular therapy products manufacturing and distribution, clinical services, and clinical research. Participates in product development and IND/clinical trial monitoring activities to ensure that quality and cGMP requirements are met.
Essential job functions:
Supervise, train and mentor assigned staff
Ensure that cGMP requirements and quality standards are recognized, understood and maintained across all program areas.
Serve as subject matter expert in quality management, interpretation of FDA regulations and guidance relevant to HCT/Ps and clinical trials, and FACT accreditation standards
Manage all aspects of the quality system for assigned program areas
Review/release of batch records
Engage with operations to problem solve and address complex issues that may impact the quality and safety of products and services
Perform quality monitoring and assessment activities, analyze data, prepare reports, and lead quality review meetings
Facilitate/lead improvement projects and verify effectiveness
Participate in new product development projects, guiding transition from R&D to cGMP production standards
Participate in the development of SOPs, forms and preparation of IND and BLA submissions
Manage regulatory and accreditation inspections and customer audits of the assigned program areas
To qualify, you must have a Bachelors’ Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management, with at least five years of quality assurance experience in a healthcare or drugs/biologics/medical devices manufacturing setting, and one year managing people, projects or programs. Experience in cellular therapy manufacturing setting is a plus. The ability to effectively supervise staff, and knowledge of applicable regulations and standards will be expected, as will superior problem-solving, analytical, organizational and oral/written communication skills.
Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations
Internal Number: 2019-2235
About New York Blood Center
Founded in 1964, New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the world. NYBC, along with its partner organizations Community Blood Center of Kansas City, Missouri (CBC), Innovative Blood Resources (IBR), Blood Bank of Delmarva (BBD), and Rhode Island Blood Center (RIBC), collect approximately 4,000 units of blood products each day and serve local communities of more than 45 million people in the Tri-State area (NY, NJ, CT), Mid Atlantic area (PA, DE, MD), the Kansas City metropolitan area, Minnesota, Nebraska, Rhode Island, and Southern New England. NYBC and its partners also provide a wide array of transfusion-related medical services, including Comprehensive Cell Solutions, the National Center for Blood Group Genomics, the National Cord Blood Program, and the Lindsley F. Kimball Research Institute, which — among other milestones — developed the Hepatitis B vaccine and a patented solvent detergent plasma process innovating blood-purification technology worldwide.