Director - Quality and Regulatory Compliance CCS (Comprehensive Cell Solutions)

The Director, Quality and Regulatory Compliance (CCS) leads quality, compliance, and regulatory initiatives in support of NYBCe's Comprehensive Cell Solutions (CCS) business unit across all geographic regions, including cell therapy collections, product development, clinical trials, and contract manufacturing of cellular therapies. Reporting to the SVP of Quality and Regulatory Affairs, the Director provides focused oversight of quality systems within CCS to ensure compliance with regulatory and corporate requirements. This role 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. She/he manages quality-related interactions with CCS clients, including customer audits and the development of quality agreements. The Director participates in establishing a regulatory strategy for CCS-initiated product development projects and preparing regulatory submissions. She/he may represent NYBCe to regulatory and accrediting agencies. The Director applies strong leadership skills to motivate, coach, develop, and retain high-performing Quality staff, and fosters a quality-oriented culture throughout the organization.

Candidates Must Have Cell Therapy Experience

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.

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 Qualification:

• Experience providing quality management oversight in a cell therapy manufacturing environment strongly preferred.

NOTE: Must be able to travel domestically up to 20%.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $165,000.00p/yr. to $175,000.00p/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.

Founded in 1964, New York Blood Center Enterprises (NYBCe) has provided more than 60 years of lifesaving research, innovation, and impact. NYBCe is one of the largest nonprofit blood centers, spanning 17 states and serving 75 million people. NYBCe operates Blood Bank of Delmarva, Community Blood Center of Kansas City, Connecticut Blood Center, Memorial Blood Centers, Nebraska Community Blood Bank, New Jersey Blood Services, New York Blood Center, and Rhode Island Blood Center, delivering one million blood products to 400 U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200 research, academic, and biopharmaceutical organizations. NYBCe's Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.