Executive Director, Regional Quality and Regulatory Affairs Specialist

1 week ago


Louisville, Kentucky, United States American Society for Quality Full time
About the Role

The American Society for Quality is seeking a highly skilled Executive Director, Regional Quality and Regulatory Affairs to lead regional quality, compliance, and regulatory initiatives in support of our organization's mission.

Key Responsibilities
  • Provide focused oversight of quality systems within the region to ensure compliance with regulatory and corporate requirements.
  • Manage quality-related interactions with clients, including customer audits and the development of quality agreements.
  • Establish a regulatory strategy for product development projects, prepare regulatory submissions, and represent the organization to regulatory and accrediting agencies.
  • Apply strong leadership skills to motivate, coach, develop, and retain high-performing Quality staff, and foster a quality-oriented culture throughout the organization.
Requirements
  • Bachelor's Degree in life sciences, pharmaceutical, biotech, or biologics manufacturing, or quality management.
  • Master's degree or higher preferred.
  • 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 Qualifications
  • Experience providing quality management oversight in a cell therapy manufacturing environment.
  • Experience preparing and managing IND and/or BLA submissions to FDA.
Compensation

The proposed annual salary is commensurate with the applicant's skills, job-related knowledge, and experience.



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