Quality Assurance Manager

Job Summary:

The QA Manager is responsible for ensuring the quality and safety of cord blood processing, storage, and release, in accordance with relevant regulatory and accreditation bodies including AABB, FACT, CAP, and HSCA (MOH). This role includes implementing quality management systems, conducting audits, training staff, and ensuring adherence to operational and safety standards within the facility, while maintaining compliance with GxP (Good Clinical Practice, Good Laboratory Practice, and Good Documentation Practice).

Key Responsibilities:

• Develop, implement, and monitor quality assurance policies and procedures for the cord blood banking process.
• Lead internal and external audits, ensuring compliance with regulatory requirements and industry best practices.
• Prepare for and manage inspections from accrediting bodies such as AABB, FACT, CAP, and HSCA (MOH).
• Monitor and report on quality indicators, ensuring timely corrective actions when necessary.
• Ensure that the laboratory team follows all SOPs and complies with the necessary accreditation standards.
• Conduct training for laboratory and clinical staff on quality management systems, SOPs, regulatory requirements, and GxP principles (GCP, GLP, and GDP).
• Maintain accurate records of all quality-related activities, ensuring audit-readiness at all times.
• Collaborate with other departments to address any non-conformances and initiate corrective and preventive actions.

Qualifications:

• Bachelor’s degree in Life Sciences, Quality Assurance, or related field.
• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor) preferred.
• Minimum 3 years of experience in quality assurance in a regulated environment, preferably in the cord blood banking or biobanking sector or healthcare laboratory environment.
• In-depth knowledge of accreditation requirements (AABB, FACT, CAP, HSCA) and GxP standards (GCP, GLP, GDP).
• Strong analytical, problem-solving, and communication skills.