Quality Systems Leader – GMP & CAPA (Hybrid)

Oxford Global Resources; Hoofddorp; Hybrid; EUR 65,000 - 89,000; Full time

Benefits offered by this job

Hybrid working

6 month contract through Oxford Global

Job summary

Oxford Global Resources is seeking a Senior Specialist I, Quality Systems to oversee the Quality Management System within a GMP-regulated biopharma operation, driving compliance and continuous improvement. You will partner across functions to support audits, regulatory inspections, and quality governance.

You will own Change Control, Deviations, CAPA and Material Review processes, mentor team members, and contribute to strategic quality initiatives.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 5+ years of QA experience in GMP pharma/biotech.
• Knowledge of EU GMP, ICH Q10, and quality systems.
• Experience with Change Control, Deviations, CAPA, and internal audits.
• Aseptic manufacturing understanding and strong documentation practices.
• Proficiency in Office and electronic QA systems.

Responsibilities

• Oversee Quality System processes in line with GMP and internal standards.
• Lead Change Control, Deviations, and CAPA activities and training.
• Chair quality review boards and coordinate cross-site committees.
• Manage Material Review Board activities and disposition decisions.
• Ensure regulatory inspections readiness and internal audits.
• Monitor quality metrics and drive continuous improvement.

Skills

Quality Assurance

Regulatory knowledge

Strong English communication

Independent working

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Chemistry, Microbiology, Engineering

Tools

Smartsheet

Power BI

Power Automate

Microsoft Excel

Job description

Oxford Global Resources is seeking a Senior Specialist I, Quality Systems to oversee the Quality Management System within a GMP-regulated biopharma operation, driving compliance and continuous improvement. You will partner across functions to support audits, regulatory inspections, and quality governance.

You will own Change Control, Deviations, CAPA and Material Review processes, mentor team members, and contribute to strategic quality initiatives.