Quality Assurance Manager

Vaccine Industrial Company; Riyadh; On-site; SAR 150,000 - 200,000; Full time

Job summary

A biopharmaceutical company in Riyadh is looking for a QA Manager to oversee all quality assurance activities for a new vaccine manufacturing facility. The role includes developing quality management systems and ensuring compliance with cGMP and international standards. Candidates must have a minimum of 15 years of QA experience in biopharmaceuticals, including 10 in management, and possess strong knowledge of quality regulations and cleanroom qualifications. This position offers a vital role in the successful startup of a state-of-the-art facility.

Qualifications

• Minimum 15 years of QA experience in biopharmaceutical or vaccine manufacturing, including at least 10 years in a managerial role.
• Proven experience in greenfield or technology transfer projects (vaccine or biological manufacturing preferred).
• Strong knowledge of cGMP, WHO TRS, ICH Q-series guidelines, and regulatory expectations for vaccine manufacturing.

Responsibilities

• Develop, implement, and manage the site quality management system (QMS) in line with global cGMP requirements.
• Oversee quality aspects during facility construction, equipment installation, commissioning, and qualification.
• Lead the preparation and review of SOPs, quality manuals, batch records, and validation documentation.

Skills

Leadership

Communication

Cross-functional collaboration

Knowledge of cGMP

Experience in QA systems

Tools

eQMS

Job description

The QA Manager will oversee all quality assurance activities for a greenfield human vaccine manufacturing facility currently under construction. This position is responsible for establishing, implementing, and maintaining quality systems to ensure compliance with cGMP, PIC/S, WHO, SFDA, and international regulatory standards. The role involves close coordination with cross‑functional teams including engineering, operations, validation, and regulatory affairs to ensure quality is integrated into every stage of facility design, construction, and startup.

Responsibilities

• Develop, implement, and manage the site quality management system (QMS) in line with global cGMP requirements.
• Oversee quality aspects during facility construction, equipment installation, commissioning, and qualification.
• Provide QA oversight for validation protocols (DQ, IQ, OQ, PQ), technology transfer, and process qualification.
• Lead the preparation and review of SOPs, quality manuals, batch records, and validation documentation.
• Review and approve batch documentation, deviations, etc. prior to product release.
• Coordinate with engineering and project management teams to ensure compliance with design and construction quality standards.
• Ensure quality alignment with procedures for material management, manufacturing, utilities, and laboratories.
• Recruit and train QA personnel in preparation for facility operational readiness.
• Manage internal audits (providing evidence of previous experience) and support external audits or inspections by regulatory authorities (SFDA, WHO, etc.).
• Establish systems for deviation management, CAPA, change control, and document control ensuring implementation.
• Participate in supplier qualification and quality agreement management through to implementation.
• Support product licensing and WHO prequalification documentation.
• Ensure GMP training and quality programs are developed and implemented for all relevant staff.

Experience

• Minimum 15 years of QA experience in biopharmaceutical or vaccine manufacturing, including at least 10 years in a managerial role.
• Proven experience in greenfield or technology transfer projects (vaccine or biological manufacturing preferred).
• Experience in establishing and qualifying cleanrooms, utilities (WFI, HVAC, etc.), and analytical/QC laboratories.
• Strong knowledge of cGMP, WHO TRS, ICH Q-series guidelines, and regulatory expectations for vaccine manufacturing.
• Familiarity with electronic quality management systems (eQMS) and data integrity principles.
• Excellent leadership, communication, and cross‑functional collaboration skills.