KPA 1:Quality Program Management to ensure International Accreditation.
KPI
1.1.To be responsible for a quality management program that supports quality management policies, references and procedures for each key position to ensure compliance with the JACIE Quality Management System.
1.2. Responsible to implement and maintain an effective document control system that supports the JACIE Quality Management System.
1.3. Provide a quality management program that includes policies and procedures for the establishment and maintenance of written agreements.
1.4. Verify the procedures in use to review cellular theory product efficacy to consistently provide a safe and effective product.
1.5. Provide a framework for audit purposes to verify compliance with elements of the Quality Management Plan, applicable laws, regulations and standards.
1.6. Implement a process to effectively track errors, accidents, deviations, adverse events, adverse reactions, incidents and feedback (complaints/compliments).
1.7. Apply a systematic process for cellular therapy product tracking and tracing that allows tracking from the donor to the recipient for final disposition and tracing from recipient to the donor or final disposition.
1.8. Implement the necessary documentation to identify critical manufacturers, vendors, equipment, supplies, reagents, facilities and services.
1.9. Advise on the necessary validation or verification process to be followed for critical procedures
1.10. Ensure all critical validations are performed as per JACIE standards within the allocated time period, following an audit schedule.
1.11. Educate on how to evaluate the risk in changes to a process to confirm that the changes do not create an adverse impact or inherent risk elsewhere in the operation.
1.12. Establish a feedback channel to filter improvements and changes to the Quality Management System.
1.13. Be responsible for a quarterly session to review the quality of management activities with representatives in key positions in all elements of the cellular therapy program at a minimum. 
1.14. Perform innovative research in line with best practices for our leadership in the field of Quality.
1.15. Engage and participate in national and international working groups’ activities and presentations.
1.16. Establish and maintain systems to review, modify and approve all policies and Standard Operating Procedures intended to monitor compliance with JACIE Standards for the performance of the Apheresis Collection and Processing Facility.

KPA 2: Responsible for the management of the preparation/application process with Internal Stakeholders to obtain and maintain JACIE accreditation
KPI
2.1. Train collections and processing laboratories on JACIE accreditation matters as required.
2.2. Ensure there are adequate competent technical experts in the relevant areas to assist with audits 
2.3. Devise constructive action points following monthly meetings.
2.4. Work with the CTL and STS staff to ensure a collaborative effort to achieve specified timelines for preparation, accreditation and maintenance of accreditation.
2.5. Accountable to compile annual JACIE accreditation report for the department.
2.6. Responsible for the facilitation of the annual management review meeting.
2.7. Ensure continuous compliance with the JACIE Quality Management System.

KPA 3: Establish an audit program/process
KPI
3.1. Design, develop and implement an appropriate audit program for cellular therapy collections and processing laboratory.
3.2. Train and educate the CTL and STS staff on audit processes.
3.3. Roll out and conduct the necessary audits as per the audit program specifics.
3.4. Compile the audit reports based on the findings of the completed audit, to highlight identified trends and track ongoing progress.
3.5. Identify problem areas and areas for improvement for the operational areas.

KPA 4: Upskill internal and external stakeholders on the role of the JACIE Audit Process
KPI
4.1. Develop training targeting internal stakeholders for sensitisation on JACIE preparation, accreditation and maintenance of JACIE accreditation.
4.2. Conduct training targeting internal stakeholders on JACIE preparation, accreditation and maintenance of JACIE accreditation.
4.3. Ensure that the minimum personal training path is maintained.
4.4. Participate in a minimum of ten (10) hours of educational activities related to cellular therapy cell collection, processing and quality management annually.

KPA 5: Customer and Stakeholder Relationship Building
KPI
5.1. Collaborate with other stakeholders, participate and contribute in studies for partner clinical units.
5.2. Attend and extract valuable learning lessons from feedback sessions on Quality reports with partner clinical units.
5.3. Participate in outreach meetings with future clinical units to forge new relations and build on existing relations.
5.4. Perform baseline clinical audits for partner clinical units.
5.5. Participate in quality-related peer reviewed publications.
5.6. Accountable to the JACIE inspector and main point of contact during JACIE inspections.
5.7. Participate in relevant JACIE forums to remain abreast of best practice.
5.8. Present operational challenges to relevant JACIE forums sourcing solutions from the forum and external stakeholders.
5.9. Educate and motivate key role players on continuous quality improvement.
5.10. Interact with internal and external stakeholders in matters relating to the JACIE Quality Plan.
5.11. Monitor evaluate and report on trends detected to the work areas and ensure the trends are addressed in order to contribute to the continuous improvement within the Cellular Therapy and Novel Products team.
5.12. Build and maintain collaborative relationships with key stakeholders internally and externally.

KPA 6:Financial
KPI
6.1. Provide input into the development of the 5 year STS strategy and budget.
6.2. Provide input into the annual business plan including objectives, operation, man-power plans, CAPEX and OPEX budget for the JACIE Quality Department.
6.3. Monitor, investigate and address variances to the CAPEX and OPEX budget.
6.4. Continuously monitor operational expenditure and operational trends and recommend measures to ensure continuous improvement and sustainability.
6.5. Monitor performance to plan and where variances occur due to unforeseen circumstances, review business plans and make recommendations for change.