Head, Quality Control – Biotech Division

Announcement Number: DB/05/2025/QC-H02

Position Title: Head, Quality Control – 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 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:

1. Lead the design, execution and oversight of QC operations including raw materials testing, in-process controls, finished product testing and stability studies.
2. Manage analytical and microbiological laboratories supporting mRNA, recombinant protein and cell-based product platforms.
3. Ensure timely and compliant release of materials and products based on validated test methods, specifications, and regulatory standards.
4. Oversee the development, qualification and validation of analytical methods in accordance with ICH Q2 (R2) and other applicable guidelines.
5. Drive data integrity (ALCOA+), good documentation practices, and laboratory GMP compliance across all QC activities.

6. Interface with QA, Regulatory Affairs, R&D and Production to support batch disposition, investigations, and continuous improvement initiatives.

7. Prepare for and lead QC-related inspections and audits by regulatory bodies (e.g., NDA, WHO, FDA, EMA).

8. Establish and monitor departmental Kis and quality metrics; report performance trends to executive management.

9. Mentor and lead a cross-functional QC team including analysts, microbiologists, and documentation officers to achieve technical excellence.
10. Manage QC budget, infrastructure upgrades, equipment qualification and lab safety compliance.
Academic Qualifications:

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:

1. Minimum of 15 years’ experience in a GMP-regulated pharmaceutical or biopharmaceutical QC environment, with at least 5 years in a leadership role.

2. Strong technical expertise in analytical techniques (HPLC, ELISA, PCR, Bioassays), microbiological testing, and stability management.

3. Proven experience with QC oversight in mRNA vaccines, recombinant proteins, or biologic therapeutics.

4. Familiarity with international regulatory requirements including ICH, WHO TRS, FDA 21 CFR Parts 210/211, and ISO 13485.

5. Demonstrated ability to lead method transfer, validation, and regulatory inspections.

6. Strong leadership, problem-solving, project management, and team development capabilities.

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