Director of Quality Systems

4 weeks ago

Mesa, United States Biolab Holdings, Inc Full time

**Job Summary**:
**Responsibilities**:

- Develop and maintain comprehensive quality systems and procedures to ensure compliance with regulatory standards, including AATB requirements.
- Lead process improvement initiatives to enhance efficiency, effectiveness, and quality throughout the organization.
- Oversee document control processes, ensuring proper documentation, review, and approval of quality-related documents.
- Manage the Corrective and Preventive Action (CAPA) program, including investigation, root cause analysis, implementation of corrective actions, and effectiveness monitoring.
- Investigate and manage deviations from established processes, ensuring timely resolution and prevention of recurrence.
- Collaborate with cross-functional teams to implement quality-related initiatives and drive continuous improvement.
- Conduct internal audits and assessments to evaluate compliance with quality systems and regulatory requirements.
- Prepare for and participate in regulatory inspections and audits, including interactions with regulatory agencies.
- Provide leadership, guidance, and training to quality systems personnel to ensure competence and compliance with quality standards.
- Stay informed of industry trends, best practices, and regulatory updates related to tissue banking and birth tissue manufacturing.

**Qualifications**:

- Bachelor's degree in a relevant field (e.g., Biology, Chemistry, Engineering).
- Minimum of 8 years of progressive experience in quality management, with specific expertise in process improvement, document control, CAPAs, and deviations within a regulated industry (preferably tissue banking or medical device manufacturing).
- In-depth knowledge of AATB standards and regulations applicable to tissue banking operations.
- Proven track record of implementing and managing quality systems, process improvements, and compliance initiatives.
- Strong analytical skills with the ability to identify root causes and drive effective corrective actions.
- Excellent communication, leadership, and interpersonal skills, with the ability to collaborate across functions and levels of the organization.
- Experience in leading internal audits, regulatory inspections, and interactions with regulatory agencies (FDA, CBER, etc.).
- Certified Quality Auditor (CQA) or similar certification is a plus.

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