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.
