Purpose:

A pharmaceutical company is seeking a Senior Quality Manager: Plasma & Raw Materials to ensure the safety, quality, and regulatory compliance of human plasma and plasma-derived materials used in the manufacture of critical medicinal products.

This role is central to ensuring compliance with SAHPRA, EU GMP, PIC/S Annex 1, and other international regulatory standards governing biologics.

Key Purpose

To ensure the quality and safety of plasma and raw materials through supplier oversight, laboratory governance, regulatory compliance, and environmental monitoring within a GMP-regulated biologics environment.

Key Responsibilities

• Lead qualification and auditing of plasma suppliers
• Oversee testing, evaluation, and release of raw materials (QARM laboratory)
• Maintain the Plasma Master File and support SAHPRA submissions
• Ensure compliance with GMP, GDP, and regulatory requirements
• Manage environmental monitoring and contamination control programs
• Lead deviations, CAPAs, OOS investigations, and risk assessments
• Oversee SAP/LIMS systems for traceability and batch release
• Manage and develop the QARM laboratory team
• Drive continuous improvement in quality systems and processes

Qualifications:

• M.Sc in Microbiological Science, Molecular Biology, Biochemistry or related field (PhD degree preferred)

Experience:

• 5–10 years' experience in a GMP pharmaceutical environment
• Minimum 5 years' QC / microbiology laboratory experience
• Strong knowledge of GMP (EU GMP / SAHPRA / PIC/S preferred)
• Experience in supplier audits and quality systems
• SAP and LIMS experience advantageous
• Biologics, plasma, vaccines, or blood product manufacturing
• Regulatory inspection exposure (SAHPRA / EMA / FDA)
• Strong background in microbial safety, viral risk, or contamination control
• Leadership of laboratory or QA teams



Salary: Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

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