Quality Assurance Manager

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.

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 (providing evidence of previous experience) audits 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