Supervisor External Oversight QA Systems Global

About the role

Key responsibilities

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 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 we 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.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.