Executive Director, Regional Quality and Regulatory Affairs-Louisville, Kentucky - New York Blood Center Inc

At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

The Executive Director, Quality and Regulatory Affairs leads regional quality, compliance, and regulatory initiatives in support of NYBCe’s Comprehensive Cell Solutions (CCS) division, including medical programs, product development, clinical trials, and contract manufacturing of cellular therapies.  Reporting to the VP of Quality and Regulatory Affairs, the Executive Director provides focused oversight of quality systems within their region of CCS to ensure compliance with regulatory and corporate requirements. She/he manages quality-related interactions with CCS clients, including customer audits and the development of quality agreements.  The Executive Director establishes a regulatory strategy for CCS-initiated product development projects, prepares regulatory submissions, and is a representative of NYBCe to regulatory and accrediting agencies. The Executive Director applies strong leadership skills to motivate, coach, develop, and retain high-performing Quality staff, and fosters a quality-oriented culture throughout the organization.

This position will be based in Louisville, Kentucky and candidate must be able to work in Louisville Kentucky. 

• Oversee quality monitoring and improvement programs within the region, while ensuring the organization's compliance with internal and external
• 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 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.

This position will be based in Louisville, Kentucky and candidate must be able to work in Louisville Kentucky. 

Education:

• Bachelor’s Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management
• Master’s degree or higher preferred.

Related Experience:

• Twelve 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.
• Experience preparing and managing IND and/or BLA submissions to FDA preferred

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $205,000.00p/yr. to $215,000.00p/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.