Job Title: Head, Quality Control – Biotech Division
Organisation: Dei BioPharma Ltd
Duty Station: Matugga, Wakiso, Uganda
About the Company:
Dei BioPharma Ltd is a biotech and pharmaceutical research firm duly incorporated in Uganda, specializing in the development and manufacture of innovative medicines and vaccines. Our state-of-the-art manufacturing facility, situated in Matugga, Wakiso district, Uganda, shall produce high-quality medicines across a wide range of therapeutic areas.
Job Summary: The Head, Quality Control Biotech Division is a strategic and operational leadership role responsible for managing and directing all Quality Control (QC) activities across the biopharmaceutical product portfolio including mRNA vaccines, recombinant proteins and advanced biologics. The incumbent will lead QC operations encompassing analytical testing, microbiology, bioassays, environmental monitoring, method development and stability programs. This position ensures all QC operations meet global regulatory standards such as WHO PQ, EMA, US FDA and ISO 13485. The Head of QC will be accountable for laboratory compliance, method validation, team development and timely release of materials and finished products. The ideal candidate is a highly experienced quality professional with deep technical knowledge in biotech QC and regulatory expectations for biologics.
Key Duties and Responsibilities:
- Lead the design, execution and oversight of QC operations including raw materials testing, in-process controls, finished product testing and stability studies.
- Manage analytical and microbiological laboratories supporting mRNA, recombinant protein and cell-based product platforms.
- Ensure timely and compliant release of materials and products based on validated test methods, specifications, and regulatory standards.
- Oversee the development, qualification and validation of analytical methods in accordance with ICH Q2 (R2) and other applicable guidelines.
- Drive data integrity (ALCOA+), good documentation practices, and laboratory cGMP compliance across all QC activities.
- Interface with QA, Regulatory Affairs, R&D and Production to support batch disposition, investigations, and continuous improvement initiatives.
- Prepare for and lead QC-related inspections and audits by regulatory bodies (e.g., NDA, WHO, FDA, EMA).
- Establish and monitor departmental KPIs and quality metrics; report performance trends to executive management.
- Mentor and lead a cross-functional QC team including analysts, microbiologists, and documentation officers to achieve technical excellence.
- Manage QC budget, infrastructure upgrades, equipment qualification and lab safety compliance.
Qualifications, Skills and Experience:
- PhD in Biotechnology, Biochemistry, Microbiology, Analytical Chemistry, or a related life sciences discipline. Certification in cGMP, Quality Management Systems, or Laboratory Compliance is an added advantage.
Experience and Competencies:
- Minimum of 15 years’ experience in a GMP-regulated pharmaceutical or biopharmaceutical QC environment, with at least 5 years in a leadership role.
- Strong technical expertise in analytical techniques (HPLC, ELISA, PCR, Bioassays), microbiological testing, and stability management.
- Proven experience with QC oversight in mRNA vaccines, recombinant proteins, or biologic therapeutics.
- Familiarity with international regulatory requirements including ICH, WHO TRS, FDA 21 CFR Parts 210/211, and ISO 13485.
- Demonstrated ability to lead method transfer, validation, and regulatory inspections.
- Strong leadership, problem-solving, project management, and team development capabilities.
How to Apply:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)
All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
Applications should be sent by email to [email protected] with the JOB TITLE IN THE SUBJECT LINE.
Should you not hear from us within twenty-one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful.
Deadline: 12th May 2025 by 5:00 PM
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