Job Summary:

We are seeking a highly skilled and experienced Director of Quality Systems to lead our quality management team. This role is responsible for overseeing and optimizing quality systems and processes, including document control, CAPAs, deviations, and compliance with AATB standards. The ideal candidate will have a strong background in quality management, process improvement, and regulatory requirements specific to tissue banking and birth tissue manufacturing.

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.