Director, Quality Management

Job Summary The Director of Quality oversees the development, implementation, and maintenance of quality assurance programs and processes to ensure compliance with regulatory standards and drive continuous improvement across the organization. Key Responsibilities Quality Assurance:Develop and implement quality assurance policies, procedures, and standards aligned with industry regulationsMonitor and assess processes to maintain compliance with relevant quality standards (e.g., FDA, ISO)Process Improvement:Identify areas for quality improvement and lead initiatives to enhance operational efficiency and effectivenessImplement best practices and quality improvement methodologiesAuditing and Compliance:Conduct internal audits to evaluate adherence to quality standards and regulatory requirementsCollaborate with regulatory agencies and oversee external auditsTraining and Development:Develop training programs and materials to ensure staff understanding and compliance with quality standardsProvide guidance and support to teams to improve quality-related processesQuality Metrics and Reporting:Establish key performance indicators (KPIs) and metrics to measure and report on quality-related activitiesPrepare regular reports and presentations for senior management regarding quality performanceRisk Management:Identify potential risks to quality and develop strategies to mitigate and manage these risksAdditional duties as assigned. Requirements Required Bachelor's degree in a relevant field; advanced degree preferredProven experience in quality management, preferably in a regulated industryIn-depth knowledge of quality assurance methodologies, regulations, and standards COMPETENCIES Quality Assurance Process Improvement Auditing and Compliance Quality MetricsRisk ManagementTraining and Development PHYSICAL DEMANDS AND WORK ENVIRONMENT Frequently required to sitFrequently required to standFrequently required to utilize hand and finger dexterityFrequently required to talk or hear