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:
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- Develop and implement quality assurance policies, procedures, and standards aligned with industry regulations.
- Monitor and assess processes to maintain compliance with relevant quality standards (e.g., FDA, ISO).



- Process Improvement:
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- Identify areas for quality improvement and lead initiatives to enhance operational efficiency and effectiveness.
- Implement best practices and quality improvement methodologies.



- Auditing and Compliance:
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- Conduct internal audits to evaluate adherence to quality standards and regulatory requirements.
- Collaborate with regulatory agencies and oversee external audits.



- Training and Development:
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- Develop training programs and materials to ensure staff understanding and compliance with quality standards.
- Provide guidance and support to teams to improve quality-related processes.



- Quality Metrics and Reporting:
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- Establish key performance indicators (KPIs) and metrics to measure and report on quality-related activities.
- Prepare regular reports and presentations for senior management regarding quality performance.



- Risk Management:
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- Identify potential risks to quality and develop strategies to mitigate and manage these risks.



- Additional duties as assigned.


Requirements

Required


- Bachelor's degree in a relevant field; advanced degree preferred.
- Proven experience in quality management, preferably in a regulated industry.
- In-depth knowledge of quality assurance methodologies, regulations, and standards.


COMPETENCIES


- Quality Assurance



- Process Improvement



- Auditing and Compliance



- Quality Metrics



- Risk Management



- Training and Development


PHYSICAL DEMANDS AND WORK ENVIRONMENT


- Frequently required to sit.
- Frequently required to stand.
- Frequently required to utilize hand and finger dexterity.
- Frequently required to talk or hear.




Skills:

Auditing, Best Practices, Continuous Improvement, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Industry Standards, Insurance Regulations, Internal Audit, Maintain Compliance, Manual Dexterity, Metrics, Operational Strategy, Organizational Development/Management, People Management, Performance Metrics, Policy Implementation, Process Analysis, Process Improvement, Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Risk Analysis, Risk Management, Strategic Planning, Training Program Development, Training/Teaching



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