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Executive Director, Regional Quality and Regulatory Affairs-Louisville, KY

2 months ago

Louisville, Kentucky, United States New York Blood Center Full time
Overview

New York Blood Center Enterprises (NYBCe) is a leading blood center in the world, dedicated to cultivating excellence through innovation, customer service, research, and program development. We are seeking an Executive Director, Quality and Regulatory Affairs to lead regional quality, compliance, and regulatory initiatives in support of our Comprehensive Cell Solutions (CCS) division.

Responsibilities

The Executive Director will provide focused oversight of quality systems within their region of CCS to ensure compliance with regulatory and corporate requirements. Key responsibilities include:

  • Overseeing quality monitoring and improvement programs within the region
  • Leading CCS quality improvement projects dealing with broad or complex issues
  • Managing relationships with supplier and customer counterparts from a quality and regulatory point of view
  • Reviewing, authoring, and/or approving key CCS Quality Management System documents
  • Serving as a representative to accrediting and regulatory agencies
  • Advising CCS clients on operational and regulatory submission pathways and content
  • Collaborating with CCS quality and operations management to define and implement organizational goals and action plans
Qualifications

The ideal candidate will have a Bachelor's Degree in life sciences, pharmaceutical, biotech, or biologics manufacturing, or quality management, with a minimum of 12 years of combined experience in quality management and regulatory affairs related to cGMP manufacturing, clinical trial manufacturing, and/or cellular therapies. A Master's degree or higher is preferred. The candidate should have a minimum of 5 years of experience in a quality leadership role overseeing quality in a biologics, vaccine, or aseptic manufacturing environment.

Preferred qualifications include experience providing quality management oversight in a cell therapy manufacturing environment and preparing and managing IND and/or BLA submissions to FDA.

The proposed annual salary for this position is $205,000.00 to $215,000.00, depending on location and qualifications.