Biological QA Specialist, Qualified Person (QP)

Role Overview

• Act as the Qualified Person for the GMP release of biological drug products (commercial and clinical trials).
• Supervise quality standards and production processes at external manufacturing sites.
• Manage a high volume of Change Controls, Deviations, CAPAs, and OOS.
• Review and approve Master Batch Records, analytical methods, validation protocols, and Quality Agreements.
• Serve as the primary point of contact for quality topics and coordinate batch recalls if necessary.

Requirements

• University Degree in Pharmacy (essential for QP status in Spain).
• At least 1 year of experience as a Qualified Person (or Deputy) specifically with biological products (e.g., monoclonal antibodies).
• 2-5 years in QA.
• Strong preference for candidates with prior experience in Manufacturing (Bioreactors) or Quality Control (QC).
• Proficiency in English and Spanish.
• Analytical, process-oriented and capable of managing complex dossiers.

Benefits

• Global Impact: Lead the quality strategy for major worldwide launches.
• Technical Depth: A role with significant responsibility in a specialized, fast-growing biological portfolio.