Key Skills

Job Description

We are looking for a highly motivated Supervisor External Oversight QA Systems to join our Global Quality team. In this role, you will lead a team of QA Systems Officers and Assistants and play a key role in ensuring compliance with GMP standards, regulatory requirements, and internal quality procedures .As Supervisor External Oversight QA Systems, you will oversee supplier quality management activities, quality agreements, vendor complaints, and third-party audits and inspections. You will work closely with internal stakeholders and external partners to maintain and continuously improve the company’s Quality Management System. 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.

Core Responsibilities

Lead a team of QA Systems Officers to ensure compliance with GMP standards and regulatory requirements. Oversee supplier quality management, third-party audits, vendor complaints, and the maintenance of quality agreements.

Requirements

Requires a Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field with experience in a GMP-regulated QA environment. Candidates should possess strong knowledge of audits, CAPA, and quality systems, with SAP and eQMS experience being an advantage.

Benefits

• Holiday allowance
• Year-end bonus
• Personal training budget
• Flexible working hours
• Travel expense contribution
• Pension provision
• Private parking