Lead and oversee the development and implementation of a comprehensive quality management system (QMS) for cord blood banking.
Ensure compliance with accreditation standards, including AABB, FACT, CAP, and HSCA (MOH), and lead the process for regular inspections and audits.
Provide strategic direction for quality improvement initiatives across all departments.
Manage a team of QA managers and staff, providing leadership and fostering a culture of continuous quality improvement.
Oversee the preparation, implementation, and follow-up on corrective and preventive actions related to quality non-conformances.
Act as the primary point of contact for regulatory bodies, ensuring timely reporting and resolution of any compliance issues.
Develop and oversee training programs related to quality assurance, compliance, and industry standards (including GxP principles such as GCP, GLP, and GDP).
Ensure that all cord blood processing and storage practices meet or exceed quality and safety standards and comply with GxP.
Qualifications:
Master's or bachelor degree in Life Sciences, biotechnology , or related field.
At least 8 years of experience in quality assurance or quality management, with 5+ years in a leadership role.
Expertise in accreditation bodies such as AABB, FACT, CAP, and HSCA (MOH).
In-depth knowledge of GxP (GCP, GLP, and GDP) and their application within a healthcare and laboratory environment.
