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.
