Global QA Systems Lead External Oversight & Compliance

Prothya Biosolutions; Amsterdam; On-site; EUR 5,200 - 7,600; Full time

Benefits offered by this job

Holiday allowance

Training budget

Travel allowance

Parking & transport access

Job summary

Prothya Biosolutions is seeking a proactive Supervisor External Oversight QA Systems to lead a team of QA Systems Officers and Assistants within the Global Quality group. You will oversee supplier quality management, quality agreements, vendor complaints and third‑party audits, ensuring ongoing GMP compliance and continuous improvement of the QMS.

You will collaborate with internal stakeholders and external partners to maintain audit readiness and drive CAPA actions across a complex global

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or related field.
• Experience in Quality Assurance within a GMP-regulated environment.
• Strong knowledge of GMP, supplier quality management, audits, CAPA, and quality systems.
• Experience with eQMS systems and SAP is advantageous.
• Excellent organizational and communication skills.
• Strong leadership and stakeholder management capabilities.
• Analytical mindset with focus on quality and continuous improvement.
• Ability to work independently and in an international environment.

Responsibilities

• Ensure compliance with external regulatory standards and internal quality procedures.
• Coordinate and oversee external audits and inspections.
• Identify compliance gaps and ensure timely corrective actions.
• Perform final QA review of A&R records.
• Follow up on the qualified state of suppliers in SAP through QIR.
• Review URS documentation for new materials.
• Support supplier onboarding activities and Management of Change (MOC) processes.
• Coordinate implementation of CAPAs.
• Ensure findings from audits and inspections are addressed effectively.
• Monitor supplier audit documentation and timely follow-up activities within the eQMS.
• Collaborate with cross-functional teams to maintain audit readiness.
• Organize and coordinate third-party audits.
• Read audit reports and communicate findings to stakeholders.
• Compile audit responses and CAPA plans.
• Monitor and follow up audit actions in the eQMS.
• Manage vendor-related complaints from initiation to closure.
• Coordinate investigations with vendors and internal teams.
• Ensure proper documentation, tracking, and resolution of complaints.
• Create quality agreements for new suppliers.
• Maintain and periodically review existing quality agreements.
• Ensure agreements remain compliant and up to date.
• Analyze audit findings, complaints, and quality data to identify trends and opportunities for improvement.
• Drive continuous improvement initiatives within quality processes and systems.
• Support optimization of quality management activities and compliance processes.

Skills

Leadership

Stakeholder management

Quality assurance

GMP knowledge

eQMS knowledge

SAP experience

Communication

Analytical thinking

Education

Bachelor’s or Master’s degree in Life Sciences or related field

Tools

SAP

eQMS

Job description

Prothya Biosolutions is seeking a proactive Supervisor External Oversight QA Systems to lead a team of QA Systems Officers and Assistants within the Global Quality group. You will oversee supplier quality management, quality agreements, vendor complaints and third‑party audits, ensuring ongoing GMP compliance and continuous improvement of the QMS.

You will collaborate with internal stakeholders and external partners to maintain audit readiness and drive CAPA actions across a complex global