QA Systems and Compliance Expert

Real; Breda; On-site; EUR 55,000 - 90,000; Full time

Job summary

Real is seeking a QA Systems & Compliance Expert for a leading global healthcare organization focused on radioligand therapies and GMP manufacturing in Breda. The role maintains and improves the Quality Management System to ensure regulatory compliance and site readiness.

You will collaborate across operations, quality, and suppliers to drive CAPA, data integrity, change control, and continuous quality improvement, supporting inspections and governance.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field.
• Experience in Quality Assurance within GMP-regulated pharma/biotech environments.
• Strong knowledge of Quality Systems and GMP regulations.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Ensure GMP, regulatory, and data integrity compliance.
• Manage quality documentation lifecycle (review, approval, archiving).
• Perform gap assessments and implement global quality procedures.
• Coordinate CAPA activities and effectiveness checks.
• Support deviation, incident, and quality event management.
• Review and approve routine and complex change controls.
• Plan and execute Product Quality Reviews (PQR/APQR).
• Monitor and report quality KPIs and KQIs.
• Maintain inspection readiness and support regulatory inspections and audits.
• Manage supplier qualification activities, audits, and quality agreements.
• Support incoming material quality oversight and supplier compliance.
• Support complaint management and tracking activities.
• Drive data integrity and eCompliance initiatives.
• Support quality governance meetings and self-inspections.
• Participate in global quality projects and continuous improvement initiatives.

Skills

Quality Assurance

GMP regulations

CAPA

Deviations

Change control

Audit management

Supplier quality management

Data integrity

Analytical skills

Stakeholder management

Education

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field

Job description

Contract: Temporary - Assignment until end of 2026 (sickness cover, extension possible but not guaranteed)

Location: Breda Area, Netherlands (Onsite)

Hours: Full-time

Sector: Radiopharmaceutical / GMP / Quality Assurance

About the Role

We are seeking a QA Systems & Compliance Expert for a leading global healthcare organization focused on radioligand therapies and GMP manufacturing.

This position plays a key role in maintaining and improving the site's Quality Management System (QMS), ensuring GMP compliance, inspection readiness, supplier quality oversight, and continuous quality improvement. The role supports a broad range of quality systems activities and acts as a key partner across operations, quality, and external suppliers to ensure regulatory compliance and operational excellence.

Key Responsibilities

• Maintain and continuously improve the Quality Management System (QMS)
• Ensure compliance with GMP, regulatory requirements, and data integrity standards
• Manage quality documentation lifecycle, including review, approval, and archiving
• Perform gap assessments and implement global quality procedures
• Coordinate CAPA activities and effectiveness checks
• Support deviation, incident, and quality event management
• Review and approve routine and complex change controls
• Plan and execute Product Quality Reviews (PQR/APQR)
• Monitor and report quality KPIs and KQIs
• Maintain inspection readiness and support regulatory inspections and auditsManage supplier qualification activities, audits, and quality agreements
• Support incoming material quality oversight and supplier compliance
• Support complaint management and tracking activities
• Drive data integrity and eCompliance initiatives
• Support quality management reviews, self-inspections, and quality governance meetings
• Participate in global quality projects and continuous improvement initiatives

Who We're Looking For

• Bachelor's degree or equivalent in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field
• Experience within Quality Assurance in a GMP-regulated pharmaceutical, biotech, or life sciences environment
• Strong knowledge of Quality Systems and GMP regulations
• Experience with CAPA, deviations, change control, and audit management
• Understanding of supplier quality management and qualification processes
• Strong analytical skills and attention to detail
• Excellent communication and stakeholder management skills
• Fluent English (spoken and written)

Preferred

• Experience with Product Quality Reviews (PQR/APQR)
• Experience supporting health authority inspections
• Experience within sterile manufacturing, radiopharmaceuticals, biotechnology, or advanced therapies
• Knowledge of data integrity and electronic quality systems