Head, Quality Assurance – Biotech Division

Announcement Number: DB/05/2025/QA-H01

Position Title: Head, Quality Assurance – Biotech 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 Biotech Division is a senior leadership role responsible for developing, leading and enforcing the quality assurance strategy for the biotech manufacturing facility, including mRNA vaccines, recombinant proteins, cell-based therapeutics and other advanced biologics. The incumbent will ensure the implementation and continuous improvement of quality systems in compliance with global standards including GMP (ICH, WHO, EMA, US FDA), ISO 13485 (as applicable) and national regulatory authority guidelines. The Head QA will be directly involved in quality governance, risk management, internal and external audits and oversight of batch disposition, quality control and compliance assurance processes. The role requires a high-caliber professional with demonstrated excellence in biologics QA leadership and regulatory preparedness.

Key Duties and Responsibilities:

1. Lead the development and execution of the QA strategy for biologics, mRNA and cell therapy operations.

2. Establish and maintain robust quality systems for manufacturing, testing, and release of biological products in accordance with cMP.

3. Oversee QA operations including batch review, deviation management, CAPA, change control, document control and internal audit programs.
4. Serve as the site quality lead during regulatory inspections (e.g.. NDA, WHO PQ, EMA, US FDA) and client audits.
5. Provide scientific and regulatory guidance on validation, aseptic processing, sterility assurance, and environmental monitoring.
6. Collaborate cross-functionally with QC, Regulatory Affairs, Production, and Engineering to ensure quality by design (QbD) and continuous improvement.

7. Approve master documents including SOPs, BMRs, quality manuals and validation protocols/reports.

8. Lead quality training programs and mentor the QA team to build technical strength and regulatory awareness.

9. Oversee trending and quality metrics (KPis), ensure timely reporting and lead Quality Management Review (QMR) forums.

10. Ensure product disposition decisions are based on risk assessments, compliance findings and data integrity.

Academic Qualifications:

1. PhD in Biotechnology, Biopharmaceutical Sciences, Quality Systems, Pharmaceutical Sciences, or a closely related field. Additional certifications in GMP, ISO 13485, or Regulatory Affairs are highly desirable.

Experience and Competencies:

1. Minimum of 15 years’ experience in pharmaceutical or biopharmaceutical manufacturing, with at least 5 years in a senior A leadership role.
2. Extensive knowledge of regulatory requirements for biologics and vaccines (e.g., ICH Q-series, WHO TRS, US FDA 21 CFR Parts 210/211/600/610).
3. Demonstrated experience in leading QA for sterile manufacturing, biosafety level facilities or mRNA platforms.
4. Proven ability to interface with regulatory authorities and respond to GMP inspections and audits.
5. Strong analytical, decision-making and communication skills with high ethical and compliance standards.
6. Leadership experience in setting up and scaling quality systems in a biotech or biologics manufacturing setting.

All applicants under consideration will be required to pass medical and security certifications.

EQUAL OPPORTUNITY EMPLOYER: Dei BioPharma Ltd, provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation or marital status.

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 recruitment@deibiopharma. com 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 5:00PM