Executive Director, Regional Quality and Regulatory Affairs Specialist
1 week ago
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.
- 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.
- Experience providing quality management oversight in a cell therapy manufacturing environment.
- Experience preparing and managing IND and/or BLA submissions to FDA.
The proposed annual salary is commensurate with the applicant's skills, job-related knowledge, and experience.
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