Senior Associate I– Quality Complaints, Breda

The Senior Associate I– Quality Complaints is responsible for managing product quality complaint investigations for commercial and clinical products in compliance with internal procedures and global regulatory requirements. The role supports the complaint handling and surveillance process by ensuring investigations arecompleted accurately and within defined timelines, while collaborating with internal stakeholders, manufacturing sites, suppliers, and contract manufacturers.

This position contributes to maintaining compliant quality systems, supporting regulatory inspection readiness, and driving continuous improvement through complaint trend analysis and quality oversight.

Responsibilities

Initiate and manage product quality complaint investigations and safety-related quality investigations

Perform complaint assessments in accordance with complaint handling procedures and regulatory guidelines

Ensure investigations and assessments are completed accurately, documented appropriately, and closed within required timelines

Coordinate with internal teams, manufacturing sites, suppliers, and contract manufacturers to resolve complaint investigationsEscalate potential quality or compliance issues to management when necessary

Support continuous improvement initiatives by identifying recurring issues and trends from complaint data

Participate in regulatory inspections, internal audits, and third-party audits related to complaint handling processes

Maintain compliance with GMP, quality standards, and applicable regulatory requirements

Collaborate effectively within a matrixed and cross-functional environment

Qualifications

Master’s degree OR Bachelor’s degree with 2+ years of Quality experience OR Associate’s degree with 6+ years of Quality experience

High school diploma/GED with 8+ years of Quality experience

Strong ability to manage workload and prioritize tasks within defined timelines

Effective organizational, communication, and problem-solving skillsAbility to consistently deliver accurate and high-quality work

Familiarity with project management tools and systems

Comfortable working in collaborative and cross-functional teams

Preferred Experience

Experience in biotechnology, pharmaceutical, or regulated manufacturing environments

Bachelor’s degree in a scientific discipline preferred

Experience with quality assurance, complaint handling, or manufacturing quality systems

Understanding of manufacturing and testing processes, including:

Drug substance manufacturing

Drug product manufacturing

Knowledge of GMP regulations and regulatory inspection expectations

Experience working with external suppliers, manufacturers, or global quality teams

Interested? Apply now or send CV to

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