The Senior Manager QA is responsible for overseeing the overall quality management system (QMS) of the cord blood banking operations, ensuring compliance with all relevant accreditation standards, and maintaining a continuous culture of quality improvement. This role involves strategic oversight, leadership of the QA department, and liaison with regulatory agencies and accrediting bodies such as AABB, FACT, CAP, and HSCA (MOH). The Senior Manager QA ensures that the entire operation adheres to GxP standards, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP).

Job Responsibilities

• 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

Job Requirements

• 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.

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*Only shortlisted candidate would be notified*

EA Reg. No: R22105614 | Chua Pei Jie

EA Lic. No: 15C7752