QA Complaints Specialist (GMP), Breda

The Company:

Our client is a global biotechnology company focused on developing innovative medicines for serious diseases, with a major European operations and distribution center in Breda, Netherlands. The organization supports clinical research, packaging, supply chain, and healthcare collaboration across Europe while working in areas such as oncology, cardiovascular diseases, inflammation, and rare diseases.Role Description

We are seeking a QA Complaints Specialist (GMP) to oversee and manage product quality complaints within the company's Quality Complaints and Surveillance team. The role involves ensuring timely and accurate investigation of complaints, supporting regulatory compliance, and driving process improvements in line with internal standards and external requirements. The Senior Associate will play a key part in safeguarding product quality and compliance across both commercial and clinical operations.Responsibilities

Lead and own product quality and safety complaint investigations, ensuring thorough assessments are completed accurately and within specified timelines. Collaborate with assessors across different sites and external partners to resolve complaints and investigate issues effectively. Escalate potential quality concerns to management promptly.Participate in regulatory inspections and audits related to complaint handling processes. Support continuous improvement initiatives by translating market feedback into actionable insights. Maintain compliance with GMP, regulatory, and internal quality standards throughout the investigation process.Requirements

Master’s degree OR Bachelor’s degree with 2+ years of experience in Quality, OR Associate’s degree with 6+ years of relevant experience, OR high school diploma with 8+ years of Quality experience. Experience in biotech or pharmaceutical manufacturing environments preferred. Ability to manage workload efficiently and meet deadlines.Strong team collaboration skills and ability to operate within a matrixed environment. Knowledge of manufacturing/testing processes such as API, drug substance, drug product, packaging, or medical device manufacturing.

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