Quality Systems Specialist II
Job ID: 246659
Published Date: Dec 17th, 2025
Location: Antwerp, Belgium
Summary:
Supports compliance, maintenance and improvement of the global quality management system. Assists in all quality system activities. Supports development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and internal corporate requirements.
Project Details:
- Actively participate in audit preparation efforts by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulations and standards.
- Responsible for supporting generation of QMS documentation using Electronic Document Management System (EDMS).
- Support coordination of document and record retention program for the site in alignment with the internal corporate requirements.
- Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance.
- Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
- Maintain processes/procedures to ensure compliance to internal and external requirements.
- Provide compliance support for Quality Assurance, Regulatory Affairs, R&D, and Operations to assure regulatory compliance and appropriate business planning.
Job Experience:
- Understanding of manufacturing procedures and GMP requirements is a plus
- Experience in Change Management, Inspection and CAPA Management is an added advantage
- A proven ability to work creatively and analytically in a problem-solving and process-oriented environment
- Expected to operate independently, accountable to proactively fulfill tasks and achieve results within assigned timelines
- A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives
Language Required: English;Dutch
Oxford is an Equal Opportunity Employer. All applicants will receive consideration for employment without regard to race, ethnic origin, religion, sex, age, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. All persons hired will be required to verify identity and eligibility to work in the Country in which they have applied to work.
