Open role
Supervisor External Oversight QA Systems Global
Prothya Biosolutions Netherlands B.V.
What you'll do
External Oversight & Compliance
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
Audit & Inspection Follow-up
Coordinate implementation of corrective and preventive actions (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
Third-Party Audit Management
Organize and coordinate third-party audits
Review audit reports and communicate findings to stakeholders
Compile audit responses and CAPA plans
Monitor and follow up audit actions in the eQMS
Complaint to Vendor Management
Manage vendor-related complaints from initiation to closure
Coordinate investigations with vendors and internal teams
Ensure proper documentation, tracking, and resolution of complaints
Quality Agreement Management
Create quality agreements for new suppliers
Maintain and periodically review existing quality agreements
Ensure agreements remain compliant and up to date
Continuous Improvement
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
What you'll bring
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Quality Management, or a 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 considered an advantage
Excellent organizational and communication skills
Strong leadership and stakeholder management capabilities
Analytical mindset with a focus on quality and continuous improvement
Ability to work independently and collaboratively in an international environment
What's on offer
A market-rate salary
A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
A personal training budget of €2,100 every three years to foster professional growth and development.
Flexible working hours after deliberation
Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
Contribution to travel expenses from the first kilometer
Excellent accessibility by public transport and private parking available.
Sound pension provision.