Quality Officer for Stem Cell at The African Medical Centre of Excellence (AMCE)

Job Purpose

• The Quality Officer for the Stem Cell Laboratory will ensure the highest standards of quality, safety, and regulatory compliance within all stem cell processing, storage, and research activities. This role is responsible for implementing and maintaining a robust quality management system, overseeing documentation, conducting audits, and ensuring adherence to national and international standards for stem cell banking and therapy.

Key Accountabilities/Responsibilities

Quality System Management

• Develop, implement, and maintain a quality management system (QMS) specific to stem cell processing and banking in compliance with applicable regulations.
• Manage all controlled documentation, including standard operating procedures (SOPs), batch records, validation protocols, and quality records.
• Oversee the laboratory’s deviation, non-conformance, and corrective/preventive action (CAPA) processes.

Regulatory Compliance & Accreditation

• Ensure compliance with relevant national regulations (NAFDAC, MLSCN) and international standards (FACT-JACIE, AABB, ISO 15189, ISBT 128).
• Lead preparations for external inspections, audits, and accreditation processes for the stem cell laboratory.
• Monitor evolving regulatory landscapes for cell and gene therapies and implement necessary updates.

Regulatory Compliance & Accreditation

• Ensure compliance with relevant national regulations (NAFDAC, MLSCN) and international standards (FACT-JACIE, AABB, ISO 15189, ISBT 128).
• Lead preparations for external inspections, audits, and accreditation processes for the stem cell laboratory.
• Monitor evolving regulatory landscapes for cell and gene therapies and implement necessary updates.

Product & Process Oversight

• Review batch manufacturing records for stem cell products to ensure compliance with SOPs and release specifications.
• Manage the quarantine and release process for incoming donor material and final stem cell products.
• Oversee the management of critical reagents and materials, ensuring traceability and quality.

Product & Process Oversight

• Review batch manufacturing records for stem cell products to ensure compliance with SOPs and release specifications.
• Manage the quarantine and release process for incoming donor material and final stem cell products.
• Oversee the management of critical reagents and materials, ensuring traceability and quality.

Qualifications

• Bachelor’s degree in Medical Laboratory Science, Biomedical Sciences, Cell Biology, or a related life science field.
• Certification in Quality Management (e.g., CQA, ISO Lead Auditor) or specific stem cell/cellular therapy quality training is highly desirable.
• Minimum of 3 years of experience in a quality assurance role within a stem cell laboratory, cellular therapy facility, blood bank, or similarly regulated biological manufacturing environment.

Experience

• In-depth knowledge of quality standards and regulations specific to cellular therapies (e.g., FACT-JACIE, AABB Standards, GMP/GTP).
• Hands-on experience with quality systems in a GMP/GTP-compliant cleanroom or processing facility.
• Proven experience in conducting internal audits, managing deviations, and leading CAPA processes.
• Excellent attention to detail, documentation skills, and organizational abilities.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a multidisciplinary scientific and clinical environment.