Quality Assurance and Regulatory Affair Officer

About Us

Ethio-BioPharma Enterprise (EBPE) is Ethiopia’s state-owned pharmaceutical manufacturing enterprise, established to build the nation’s capacity to manufacture vaccines, essential medicines, diagnostics, medical supplies and other healthcare technologies locally. Operating under EIH, EBPE is developing an integrated pharmaceutical campus at the Kilinto Special Economic Zone in Addis Ababa, co-locating multiple manufacturing units that share infrastructure,talent, and corporate services.

Job Summary

I. GENERAL POSITION DESCRIPTION

Main Purpose of the post

The Quality Assurance officer will provide strategic and operational leadership and expert oversight to establish and implement a comprehensive QA system for Ethio-biopharma Enterprise’s vaccine, Pharmaceutical & diagnostics manufacturing projects. The role ensures that all phases—design, construction, commissioning, qualification, validation, technology transfer, and operational readiness comply with EFDA, WHO PQ, and international GMP standards.

The officer develops robust, risk-based quality systems tailored to vaccine, diagnostics and pharmaceutical manufacturing, and works closely with engineers, architects, contractors, and regulators to ensure construction activities meet regulatory and industry requirements. Key responsibilities include quality oversight of construction, inspections, documentation review, vendor and equipment qualification, and leadership of URS, FAT/SAT, commissioning, and validation activities. The role also manages non-conformities and drives corrective and preventive actions.

The officer ensures the facility is built and prepared to operate as a modern, fully compliant, state-of-the-art vaccine manufacturing plant.

II. KEY RESPONSIBILITIES / ACCOUNTABILITY

A. Leadership

1. Develop and implement the Quality Strategy aligned with Ethio-biopharma’s mission, regulatory expectations, and global best practices.
2. Provide quality leadership across the enterprise and serve as the primary officer to the CEO on all quality and compliance matters.
3. Establish and lead the Quality Management System (QMS) from the project phase through full-scale manufacturing.
4. Ensure quality policies, governance structures, and performance indicators are well-defined and implemented.
5. Work closely with internal staff, international consultants, EPC contractors, and regulatory bodies.
6. Ensure GMP principles are observed in preparing architectural layouts, engineering designs, workflows, and contamination control strategies.
7. Oversee detailed design reviews for compliance for Regulatory compliance
8. Provide QA leadership during process design, method development, and validation planning.
9. Plan, coordinate and monitor the Quality Assurance activities of the enterprise

B. Establishment of the QA System (Project to Manufacturing Phase)

1. Leads the establishment of a phased QMS roadmap covering: Project Phase (non-GMP but quality-governed), Pre-Operational Phase, GMP Readiness Phase, and Commercial Manufacturing Phase.
2. Leads the design and stepwise implementation of a phase-appropriate Quality Management System (QMS) that evolves from project stage requirements to full cGMP-compliant commercial manufacturing systems.
3. Prepares all QMS documents including document control, change management, management review, deviation handling, CAPA, supplier qualification, and risk management.
4. Develops quality oversight mechanisms for technology transfer partners, contractors, including EPC contractors, and consultants.
5. Establishes systems to ensure compliance during procurement of equipment, utilities, and raw materials.
6. Ensures construction activities support smooth transition into qualification, validation, and GMP operations.

C. Regulatory Compliance & Inspection Readiness

1. Ensures full compliance with national (EFDA) and international standards (GMP, WHO, EMA where applicable).
2. Leads preparation for regulatory inspections, external audits, and prequalification (e.g., WHO PQ) processes.
3. Serves as the primary point of contact with regulatory authorities on quality matters.
4. Maintains up-to-date awareness of evolving regulations and guide the organization in implementing changes.
5. In collaboration with the RA officer for GMP & Regulatory Affairs, supports preparation and submission of facility licensing applications and product registration dossiers.
6. Supports EFDA, WHO PQ, and other international regulatory inspections and ensure inspection readiness.
7. Ensure that GMP principles and QA requirements are embedded into architectural layouts, engineering designs, workflows, personnel/material flows, and contamination control strategies.
8. Lead QA integration into planning and design activities, working closely with internal staff, international consultants, EPC contractors, regulatory bodies, and other partners.

D. Validation, Qualification & Technology Transfer Oversight

1. Oversees qualification of equipment, utilities, and cleanrooms.
2. Participates in the preparation and QA review of User Requirement Specifications (URS) for equipment, systems, and facility components.
3. Participates in Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and related inspections from a QA and compliance perspective.
4. Provides QA oversight during equipment installation, utility commissioning, and environmental system implementation.
5. Oversees quality considerations during facility design, construction, commissioning, and qualification (DQ, IQ, OQ, and PQ).
6. Approves validation master plans, validation protocols and ensure lifecycle validation of processes, cleaning, and analytical methods.
7. Provides QA oversight of technology transfer activities with international partners.
8. Ensures data integrity principles (ALCOA+, GAMP 5) are embedded in computerized systems and laboratory operations.
9. Ensure technical transfer documents, protocols, and processes meet global GMP standards.
10. Review and approve technology transfer plans, analytical method transfer protocols, and comparability assessments.
11. Ensure quality, documentation, and data integrity expectations are met during transfers from technology transfer partners.
12. Ensure readiness of facility, equipment, materials, and staff for receiving technology.
13. Participate in and approve technology transfer quality requirements.

E. Quality Governance & Documentation

1. Establishes and maintain the Document Management System.
2. Approves all quality-critical SOPs, policies, protocols, and reports.
3. Develops quality governance frameworks, including Quality manual and Management Reviews.
4. Prepares quality reports for the CEO and Board as required.

F. Building & Leading the Quality Assurance Team

1. Defines QA organizational structure and staffing plan appropriate for each project phase.
2. Recruit, train, mentor, and evaluate QA personnel to build a high-performing quality culture.
3. Promotes a strong culture of compliance, continuous improvement, and ethical conduct across the enterprise.

G. Project execution Quality Oversight

1. Review design documents, construction drawings, specifications, and change orders for ultimate quality compliance.
2. Ensure implementation alignment with regulatory requirements (EFDA, WHO PQ, and GMP).
3. Provide QA oversight during material selection, equipment procurement, installation, and commissioning.
4. Verify that critical materials (e.g., cleanroom panels, flooring, stainless steel piping, etc.) meet standards and compliant, traceable, and suitable for later qualification and validation.
5. Work closely with consultants, engineering, contractors, procurement, and regulatory teams.
6. Prepare and support inspections and audits during and after construction.
7. Ensure accurate, complete, and controlled documentation for all project/construction activities.

H. Training, Auditing, and Technical Leadership

1. Provide capacity-building initiatives by training internal staff, engineers, and operational teams on QA principles, GMP standards, contamination control, validation and regulatory expectations.
2. Lead Core Quality Assurance operations like Self inspection/Internal audit, Annual product review, Out of Specification/Out of trend activities, and the like
3. Conduct internal QA audits, gap assessments, deviation investigations, and CAPA management to drive continuous compliance improvement.
4. Provides QA and regulatory input on technology transfer, process design, documentation systems, and operational readiness.
5. Conduct periodic training on GMP, data integrity, and quality systems.

I. Operational Quality Oversight

1. Oversee batch review, release procedures, and product disposition systems.
2. Ensure Quality Risk Management (ICH Q9) is integrated into all operations.
3. Build and oversee Good Documentation Practices (GDP) across the enterprise.
4. Establish systems for complaints handling, product recall, and market surveillance.
5. Ensure control of materials, supplier qualification, and vendor audits.

J. Continuous Improvement

1. Lead continuous improvement initiatives using QRM, and other appropriate quality management tools.
2. Analyze quality metrics and trends to drive preventive actions.
3. Implement digitalization initiatives for QMS automation and data integrity strengthening.

K. Reporting and Planning

1. Prepare weekly, monthly, quarterly, and annual QA work plans and performance reports for the CEO.
2. Report on QA system establishment progress, validation and qualification status, risk assessments, internal audit, annual product review, regulatory compliance, etc..
3. Provide strategic recommendations on quality risks and mitigation measures.

L. Authority

1. Authorized for technical document approval, issuance and archive
2. Approve/reject materials & products; batch release/rejection
3. Approve SOPs, test methods, protocols, investigations, monitoring programs, and quality related project documents
4. Approve training programs, operator qualifications
5. Authorized for Line clearance, contamination control, process oversight
6. Authorized to evaluate and address contractor/vendor non-compliance and recommend corrective preventive actions
7. Approve quality related deliverables of consultants
8. Authorized to approve, Validation Master Plans (VMPs), validation, qualification, and vendor-qualification.
9. Block or quarantine any material or product that does not meet specifications.
10. Suspend production activities during deviations, contamination risks, or facility failures.
11. Stop any operation that poses a quality, GMP, safety, or data integrity risk.
12. Approve URS (User Requirement Specifications) for all GMP critical systems/equipment.
13. Authorize changes through the Change Control procedure.
14. Authorize document issuance and archival.
15. Approve final deviation, CAPA, OOS, OOT investigations.

M. Effort required

1. Requires continuous analytical judgment, regulatory decision-making, and mental concentration.
2. Involves periodic on-site inspections, facility walkthroughs, FAT/SAT witnessing, and construction oversight.
3. Requires strong leadership in a multidisciplinary, fast-paced project environment.

The Quality Assurance and Regulatory Affair Officer is expected to carry out other related tasks as assigned by pertinent authority

Reports to: This positions reports to the CEO

Salary: As per the Organization's Scale