Logistics Quality Associate

Real; Antwerpen; Hybride; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Real is seeking a Logistics Quality Associate to manage quality events, NCs, CAPAs, and investigations within a GxP-regulated environment. The role acts as a liaison among Logistics, QA, Supply Chain, vendors, and other stakeholders, ensuring timely resolution of quality issues and effective CAPA implementation.

The position offers a hybrid schedule with on-site presence 1 day per week and remote work for the remaining days, supporting continuous improvement across logistics and supply chain

Qualifications

• Bachelor's degree in Supply Chain, Life Sciences, Quality Management, Engineering, Business Administration, or equivalent experience.
• Minimum 3 years of experience in pharmaceutical, biotechnology, medical device, or other GxP-regulated environments.
• Experience in logistics quality, supply chain quality, quality systems, or compliance roles.
• Proven experience managing Non-Conformances, CAPAs, deviations, or quality investigations.
• Experience working in cross-functional and global organizations.

Responsabilités

• Own and manage logistics-related Non-Conformance (NC) records throughout their lifecycle within the Quality Management System (e.g., COMET, TrackWise, Veeva Quality).
• Ensure timely initiation, assessment, investigation, escalation, approval, and closure of NCs, CAPAs, and related action plans.
• Coordinate investigations with Logistics Integrators, Quality Assurance, Supply Chain teams, vendors, and external partners.
• Review Root Cause Analyses and CAPAs to ensure completeness, compliance, and effectiveness.
• Monitor investigation timelines and proactively drive closure of records.
• Escalate critical compliance risks, recurring issues, and overdue actions when necessary.
• Support impact assessments related to product quality, patient safety, and supply continuity.

Connaissances

Analytical skills

Problem solving

Communication

Stakeholder management

Project coordination

Cross-functional collaboration

Formation

Bachelor's degree in Supply Chain, Life Sciences, Quality Management, Engineering, Business Administration, or equivalent

Outils

COMET

TrackWise

Veeva Quality

Description du poste

The Logistics Quality Associate is responsible for managing logistics-related quality events, non-conformances (NCs), CAPAs, and investigations within a GxP-regulated pharmaceutical environment. This role ensures compliance with quality and regulatory requirements while supporting continuous improvement across logistics and supply chain operations.

The position serves as a key liaison between Logistics, Quality Assurance, Supply Chain, vendors, and other cross-functional stakeholders to ensure timely resolution of quality issues and effective implementation of corrective and preventive actions.

Work Schedule: This is a hybrid position requiring on-site presence 1 day per week, with the remaining days worked remotely.

Key Responsibilities

Logistics Quality Associate

The Logistics Quality Associate is responsible for managing logistics-related quality events, non-conformances (NCs), CAPAs, and investigations within a GxP-regulated pharmaceutical environment. This role ensures compliance with quality and regulatory requirements while supporting continuous improvement across logistics and supply chain operations.

The position serves as a key liaison between Logistics, Quality Assurance, Supply Chain, vendors, and other cross-functional stakeholders to ensure timely resolution of quality issues and effective implementation of corrective and preventive actions.

Work Schedule: This is a hybrid position requiring on-site presence 1 day per week, with the remaining days worked remotely.

Position Summary

The Logistics Quality Associate is responsible for managing logistics-related quality events, non-conformances (NCs), CAPAs, and investigations within a GxP-regulated pharmaceutical environment. This role ensures compliance with quality and regulatory requirements while supporting continuous improvement across logistics and supply chain operations.

The position serves as a key liaison between Logistics, Quality Assurance, Supply Chain, vendors, and other cross-functional stakeholders to ensure timely resolution of quality issues and effective implementation of corrective and preventive actions.

Work Schedule: This is a hybrid position requiring on-site presence 1 day per week, with the remaining days worked remotely.

Key Responsibilities

Non-Conformance & CAPA Management

• Own and manage logistics-related Non-Conformance (NC) records throughout their lifecycle within the Quality Management System (e.g., COMET, TrackWise, Veeva Quality).
• Ensure timely initiation, assessment, investigation, escalation, approval, and closure of NCs, CAPAs, and related action plans.
• Coordinate investigations with Logistics Integrators, Quality Assurance, Supply Chain teams, vendors, and external partners.
• Review Root Cause Analyses and CAPAs to ensure completeness, compliance, and effectiveness.
• Monitor investigation timelines and proactively drive closure of records.
• Escalate critical compliance risks, recurring issues, and overdue actions when necessary.
• Support impact assessments related to product quality, patient safety, and supply continuity.

Quality Systems & Compliance

• Ensure compliance with GMP, GDP, company procedures, and quality standards.
• Maintain inspection-ready documentation and records.
• Support audit and inspection activities by providing quality event documentation and subject matter expertise.
• Identify opportunities for process improvement and prevention of recurring quality issues.
• Contribute to continuous improvement initiatives within logistics quality operations.

Governance & Reporting

• Track and report NC and CAPA performance metrics.
• Maintain KPI dashboards related to timeliness, record aging, CAPA effectiveness, and investigation quality.
• Present quality event status and progress updates during CAPA Boards and governance meetings.
• Communicate trends, risks, and improvement opportunities to leadership and stakeholders.

Preferred Qualifications

Education

• Bachelor's degree in Supply Chain, Life Sciences, Quality Management, Engineering, Business Administration, or equivalent experience.

Experience

• Minimum 3 years of experience in pharmaceutical, biotechnology, medical device, or other GxP-regulated environments.
• Experience in logistics quality, supply chain quality, quality systems, or compliance roles.
• Proven experience managing Non-Conformances, CAPAs, deviations, or quality investigations.
• Experience working in cross-functional and global organizations.

Technical Knowledge

• Strong knowledge of:
  • Non-Conformance Management (NC)
  • Corrective and Preventive Actions (CAPA)
  • Root Cause Analysis
  • Quality Management Systems (QMS)
  • GMP/GDP regulations
  • Risk Management principles
• Experience with:
  • COMET
  • TrackWise
  • Veeva Quality
  • Or equivalent quality management platforms

Key Skills

• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to drive investigations and manage multiple priorities simultaneously.
• Strong organizational and project coordination skills.
• Proactive mindset with attention to detail and compliance.
• Ability to collaborate effectively across global and cross-functional teams.

Desired Skills and Experience

• 3+ years of experience in pharmaceutical, biotech, or GxP-regulated logistics/quality environments.
• Strong expertise in Non-Conformance (NC), CAPA management, and Root Cause Analysis methodologies.
• Hands-on experience with Quality Management Systems such as COMET, TrackWise, or equivalent.
• Proven ability to lead cross-functional investigations and collaborate with QA, Supply Chain, and external partners.
• Excellent analytical, communication, stakeholder management, and problem-solving skills.