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.
Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.