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

Announcement Number: DB/05/2025/QC-H04
Position Title: Head, Quality Control – 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 Control Vaccine Division is a senior leadership role responsible for overseeing all quality control operations related to the manufacturing and release of vaccine products including viral, recombinant protein and mRNA-based vaccines. The position ensures compliance with WHO PQ standards, US FDA, EMA and NDA Uganda regulations through strategic leadership in analytical method validation, microbiological testing, sterility assurance, environmental monitoring and stability studies. The incumbent will lead a multidisciplinary QC team and ensure readiness for audits, inspections and market release. The ideal candidate must possess a PhD in a relevant life science field and have substantial experience in quality control of vaccines or biological products within a cGMP-compliant environment.

Key Duties and Responsibilities:

1. Lead and manage quality control laboratories (chemical, microbiological and molecular) supporting vaccine manufacturing processes.
2. Oversee method development, qualification and validation for in-process, release, and stability testing of vaccine products.
3. Ensure timely and compliant testing of raw materials, intermediates and finished products according to regulatory and internal specifications.
4. Supervise sterility, endotoxin, potency, residual DNA and microbial limit testing in alignment with pharmacopeial and WHO standards.
5. Ensure laboratory compliance with cGMP, ISO 17025, WHO TRS 1004 Annex 4, and other applicable regulatory frameworks.
6. Provide technical oversight during investigations of OOS, OOT and deviations, and support CAPA implementation.
7. Coordinate inspection and audit readiness; lead the response and remediation of regulatory or client findings.
8. Monitor environmental controls and oversee the qualification and calibration of analytical equipment and utilities.
9. Develop and mentor a high-performing QC team and promote a data-driven, risk-based approach to laboratory operations.
10. Prepare and present quality metrics, trend analyses and management review reports to executive leadership.

Academic Qualifications:
PhD in Microbiology, Biotechnology, Immunology, Biochemistry, Pharmaceutical Sciences, or a closely related field. Additional training or certification in GMP, ISO 17025, or QA/QC systems is highly desirable.

Experience and Competencies:

1. Minimum of 10 years’ experience in QC operations within the vaccine or biologics industry, with at least 5 years in a senior management or leadership capacity.
2. Expert knowledge of analytical platforms for vaccine testing: ELISA, HPLC, qPCR, cell-based assays, endotoxin detection, and sterility testing.
3. Proven experience with WHO prequalification processes, ICH guidelines, FDA/EMA expectations, and cGMP compliance.
4. Solid track record in leading laboratory audits, inspections, and regulatory submissions.
5. Strong leadership and mentoring capabilities with a commitment to scientific integrity and operational excellence.
6. Excellent communication, problem-solving, and cross-functional collaboration skills.