Head, Quality Assurance – Vaccine Division (Number of positions: 01)

Announcement Number: DB/05/2025/QA-H03
Position Title: Head, Quality Assurance – Vaccine Division (Number of positions: 01)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: Executive Management
Salary: Attractive and Commensurate with Experience
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: Yes

Job Summary:

The Head, Quality Assurance Vaccine Division is a senior-level position responsible for designing, executing and overseeing the comprehensive quality assurance framework governing vaccine manufacturing, testing and release processes. The role requires strong expertise in WHO prequalification, EMA/FDA regulations and compliance with cGMP, GCLP and ISO standards applicable to biological and vaccine products. The incumbent will ensure QA oversight of production operations, batch release, quality systems, audits and regulatory inspection readiness across the vaccine value chain. This position is central to ensuring that vaccines manufactured at DEI BioPharma meet international safety, efficacy and quality standards. The ideal candidate will hold a PhD and possess extensive experience in biologics QA systems, sterility assurance and global regulatory compliance.

Key Duties and Responsibilities:

1. Lead the development and implementation of the site-wide quality assurance system for vaccine manufacturing (viral, recombinant, and mRNA-based).
2. Ensure full compliance with WHO TRS, US FDA 21 CFR, EMA GMP Annexes and NDA Uganda regulations across all vaccine operations.
3. Oversee batch record review, product release decisions and management of deviations, change controls, and CAPA.
4. Coordinate site readiness for inspections and audits by WHO PQ, US FDA, EMA and other regulatory bodies.
5. Approve quality-critical documents including quality manuals, SOPs, validation protocols and master batch records.
6. Lead cross-functional Quality Management Review (QMR) forums and drive KPI monitoring across QA operations.
7. Provide strategic input into facility qualification, aseptic processing, cold chain validation, and product stability programs.
8. Supervise internal audit programs and ensure continual improvement aligned with QbD and risk-based approaches.
9. Mentor and develop QA managers and officers across production, quality systems, and compliance functions.
10. Ensure implementation of global data integrity principles (ALCOA+) and harmonization of documentation practices.

Academic Qualifications:
PhD in Biotechnology, Vaccine Development, Immunology, Pharmaceutical Sciences, or a related field. Additional certification in GMP, Quality Systems or Regulatory Affairs is an added advantage.

Experience and Competencies:

1. Minimum of 15 years’ experience in biopharmaceutical or vaccine manufacturing, with at least 5 years in a senior QA leadership position.
2. Demonstrated expertise in WHO Prequalification, EMA/FDA GMP compliance, and cold chain QA systems.
3. Strong technical background in vaccine production technologies (live attenuated, recombinant, mRNA).
4. In-depth knowledge of sterility assurance, aseptic validation, risk management, and quality system automation.
5. Experience in responding to regulatory inspections and driving institutional quality culture.
6. Proven leadership, strategic thinking, and capability to lead multi-disciplinary QA teams.