Senior Quality Systems Specialist - Hybrid, GMP & CAPA Lead

Oxford Global Resources; Hoofddorp; Hybrid; EUR 70,000 - 84,000; Full time

Benefits offered by this job

Hybrid working

Job summary

Oxford Global Resources is seeking a Senior Specialist I, Quality Systems to oversee and improve quality management processes in a GMP-regulated biopharma environment. You will partner with site stakeholders, manage Change Control, Deviations, and CAPA, and support regulatory inspections.

You will mentor colleagues, analyze quality metrics, and contribute to strategic quality initiatives while acting as deputy to the Senior Manager Quality Systems when needed.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Engineering or related field.
• Minimum 5 years of QA experience in GMP-regulated environments.
• Strong knowledge of EU GMP regulations and ICH Q10.
• Experience with Change Control, Deviations, CAPA, and Internal Audits.
• Experience with aseptic manufacturing and cGMP documentation.
• Proficiency with MS Office; Smartsheet, Power BI, Power Automate.

Responsibilities

• Oversee Quality System processes per GMP and internal standards.
• Chair or deputy chair for quality review boards and committees.
• Lead Deviation and CAPA processes; review/approve records.
• Coordinate Material Review Board activities and disposition decisions.
• Ensure regulatory compliance and quality policies are followed.
• Support internal/customer audits and regulatory inspections.
• Maintain cGMP documentation and controlled processes.
• Review and approve proposed changes to systems and procedures.
• Monitor quality metrics and management information.
• Identify risks and implement corrective actions.
• Support dashboards and automated reporting tools.
• Mentor team members and contribute to continuous improvement.

Skills

Quality Assurance

GMP Compliance

Change Control

CAPA

Deviations

Audits

Quality Metrics

Leadership

Cross-functional

English Proficiency

Education

Bachelor's degree in Chemistry/ Microbiology/ Engineering

Tools

Smartsheet

Power BI

Power Automate

Electronic QMS

Job description

Oxford Global Resources is seeking a Senior Specialist I, Quality Systems to oversee and improve quality management processes in a GMP-regulated biopharma environment. You will partner with site stakeholders, manage Change Control, Deviations, and CAPA, and support regulatory inspections.

You will mentor colleagues, analyze quality metrics, and contribute to strategic quality initiatives while acting as deputy to the Senior Manager Quality Systems when needed.