Head of Quality Assurance – Biotech (1 Position)

Announcement Number: DB/05/035/BT01
Position Title: Head of Quality Assurance – Biotech (1 Position)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (4)
Salary: Very Competitive
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: Yes

Summary:
DEI BioPharma Ltd., a state-of-the-art Drugs and Vaccines Manufacturing company has successfully completed the first phase of its development project. This phase includes fully equipped facilities for Oral Solid Dosage (OSD) manufacturing, Neutraceuticals, Medical Devices, and mRNA Vaccine production. As we now transition into the operational phase,  We now seek an experienced and strategic Head of Quality Assurance (Biotech) to lead and operationalize QA systems for biologics and advanced therapies. The incumbent will ensure product lifecycle compliance with cGMP, international regulatory standards, and internal quality expectations.

Key Duties and Responsibilities:

1. Establish, manage, and continually improve the Quality Management System (QMS) for biotech operations.
2. Lead QA operations across batch release, document control, deviation management, CAPA, internal audits, and supplier qualification.
3. Oversee GMP compliance during tech transfers, process validations, and clinical and commercial manufacturing.
4. Provide final QA disposition for all biologics batches, ensuring integrity of batch records, QC data, and deviation reports.
5. Serve as the principal QA liaison during regulatory inspections (FDA, EMA, WHO, NDA).
6. Drive a culture of continuous improvement and quality excellence throughout the organization.
7. Build, lead, and mentor a multidisciplinary QA team.
8. Implement QA metrics, dashboards, and compliance KPIs to drive performance and readiness.

Qualifications and Experience:

• PhD in Biotechnology, Life Sciences, or Pharmacy (Master’s with 15+ years of relevant experience may be considered).
• Minimum of 12 years’ QA experience in biotech/pharma, with at least 5 years in a leadership role.
• Deep knowledge of biologics, cell and gene therapy, or vaccine QA requirements.
• Strong command of global regulatory frameworks: FDA, EMA, WHO, ICH (Q8-Q12).

How to Apply:

1. 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)
2. All Application documents should be merged as one document in PDF or .DOC / .DOCX, which should not exceed 10MB
3. Applications should be sent by email to recruitment@deibiopharma.com with the JOB TITLE IN THE SUBJECT LINE.
4. 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 5:00PM