New York Blood Center
Director - Quality and Regulatory Compliance (Comprehensive Cell Solutions)
New York Blood Center, Rye, New York, United States
Overview
Director - Quality and Regulatory Compliance (Comprehensive Cell Solutions) – New York Blood Center. Salary: Base pay range $165,000.00/yr – $175,000.00/yr. Travel: Must be able to travel domestically up to 20%. Location note: For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $165,000.00 to $175,000.00 per year. For applicants who will perform this position outside New York City or Westchester County, salary will reflect local market rates and be commensurate with skills and experience. Note: Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations. Responsibilities
Lead quality, compliance, and regulatory initiatives in support of NYBCe’s Comprehensive Cell Solutions (CCS) across all geographic regions, including cell therapy collections, product development, clinical trials, and contract manufacturing of cellular therapies. Provide oversight of quality systems within CCS to ensure regulatory and corporate compliance. Ensure the quality and safety of NYBC products and services by applying quality principles to design, implementation, control, monitoring, assessment, and continuous improvement of work processes. Manage quality-related interactions with CCS clients, including customer audits and development of quality agreements. Participate in regulatory strategy for CCS-initiated product development projects and prepare regulatory submissions; represent NYBCe to regulatory and accrediting agencies as needed. Lead, coach, develop, and retain a high-performing Quality staff and foster a quality-oriented culture. Interface with CCS clients regarding operational and regulatory submission pathways and content; participate in preparation of CMC submissions. Collaborate with regulatory experts and consultants as needed; define and implement organizational goals and action plans with CCS quality and operations management. Oversee quality monitoring and improvement programs within CCS and ensure compliance with internal and external requirements. Review, author, and approve key CCS Quality Management System documents including SOPs, deviations, change controls, and complaints. Represent the organization to accrediting and regulatory bodies and serve as a point of contact for inspections. Mentor staff through staff development, training, and expanded experience opportunities to ensure a high-performance workforce. Participate in customer focus and engagement activities as assigned. Perform related duties as assigned. Qualifications
Education: Bachelor’s Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management Master’s degree or higher preferred Related Experience: 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 Qualifications: Experience providing quality management oversight in a cell therapy manufacturing environment strongly preferred. Travel:
Must be able to travel domestically up to 20%. EEO statement: Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.
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Director - Quality and Regulatory Compliance (Comprehensive Cell Solutions) – New York Blood Center. Salary: Base pay range $165,000.00/yr – $175,000.00/yr. Travel: Must be able to travel domestically up to 20%. Location note: For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $165,000.00 to $175,000.00 per year. For applicants who will perform this position outside New York City or Westchester County, salary will reflect local market rates and be commensurate with skills and experience. Note: Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations. Responsibilities
Lead quality, compliance, and regulatory initiatives in support of NYBCe’s Comprehensive Cell Solutions (CCS) across all geographic regions, including cell therapy collections, product development, clinical trials, and contract manufacturing of cellular therapies. Provide oversight of quality systems within CCS to ensure regulatory and corporate compliance. Ensure the quality and safety of NYBC products and services by applying quality principles to design, implementation, control, monitoring, assessment, and continuous improvement of work processes. Manage quality-related interactions with CCS clients, including customer audits and development of quality agreements. Participate in regulatory strategy for CCS-initiated product development projects and prepare regulatory submissions; represent NYBCe to regulatory and accrediting agencies as needed. Lead, coach, develop, and retain a high-performing Quality staff and foster a quality-oriented culture. Interface with CCS clients regarding operational and regulatory submission pathways and content; participate in preparation of CMC submissions. Collaborate with regulatory experts and consultants as needed; define and implement organizational goals and action plans with CCS quality and operations management. Oversee quality monitoring and improvement programs within CCS and ensure compliance with internal and external requirements. Review, author, and approve key CCS Quality Management System documents including SOPs, deviations, change controls, and complaints. Represent the organization to accrediting and regulatory bodies and serve as a point of contact for inspections. Mentor staff through staff development, training, and expanded experience opportunities to ensure a high-performance workforce. Participate in customer focus and engagement activities as assigned. Perform related duties as assigned. Qualifications
Education: Bachelor’s Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management Master’s degree or higher preferred Related Experience: 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 Qualifications: Experience providing quality management oversight in a cell therapy manufacturing environment strongly preferred. Travel:
Must be able to travel domestically up to 20%. EEO statement: Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.
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