Senior Associate Quality Assurance

Working hours: Full-time | Day shift (no shift work)
Work location: On-site, 100%
Start date: As soon as possible

About the Company
Our client is a leading international biotechnology company dedicated to developing and delivering innovative medicines to patients worldwide.

At their site in Breda, medicines are labelled, packaged, stored and distributed internationally. The location brings together professionals from various backgrounds, working across manufacturing, supply chain, quality assurance and clinical operations.

What will you do?
As a Senior Associate Quality Assurance, you will be responsible for providing quality oversight of both clinical manufacturing and clinical supply chain activities.

This position combines QA support on the production floor with documentation reviews, compliance checks and quality-related administrative activities.

You will support the labelling and packaging of clinical trial products while ensuring compliance with GMP and GDP requirements. Additionally, you will provide quality oversight throughout the clinical supply chain, from the receipt and distribution of investigational medicinal products to clinical sites and depots.

You will work closely with various departments, including Production, Warehouse, Supply Chain, Quality Assurance and Regulatory Affairs.

What are your responsibilities?

Clinical Manufacturing - QA on the Floor

• Provide QA support during clinical packaging and labelling operations.
• Perform packaging checks, label checks, batch record reviews and routine compliance checks.
• Assess and resolve quality issues arising during manufacturing activities.
• Review and approve minor deviations, ensuring compliance with GMP requirements.
• Provide quality guidance to production teams and document quality assessments.
• Support clinical manufacturing on the production floor, approximately one day per week on a rotating schedule.

Clinical Supply Chain - Quality Oversight

• Provide QA oversight of clinical trial products received, stored and distributed from the Breda site.
• Perform batch record reviews to support QP batch certification of Investigational Medicinal Products.
• Review and approve clinical label artwork.
• Assess temperature excursions during transportation and at clinical sites.
• Support investigations and resolve compliance or quality issues related to clinical supply chain activities.
• Write, review and update operational SOPs and Work Instructions.
• Ensure documentation complies with corporate, site and regulatory requirements.
• Prepare monthly quality metrics and identify opportunities for improvement.
• Collaborate with cross-functional stakeholders to resolve quality-related issues.

What do you need to be successful in this role?

• A degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related scientific field. A Master’s degree is preferred.
• Relevant Quality Assurance experience within a GMP-regulated environment. Around three years of experience is preferred, but someone with at least one year of relevant experience will also be considered.
• Experience within the pharmaceutical or medical device industry is preferred.
• Knowledge of GMP, GDP and/or GCP regulations.
• Experience with batch record reviews, deviations, investigations or other quality-related activities is an advantage.
• Strong analytical skills and attention to detail.
• Good communication skills and the ability to collaborate with different departments.
• Fluency in English.

Good to know:

• You should be comfortable performing routine documentation reviews and administrative QA activities.
• We are looking for someone interested in developing within the team and contributing over the longer term.

What will you bring?
We are looking for a motivated and detail-oriented QA professional who enjoys working in a dynamic pharmaceutical environment.

You bring:

• A strong quality and compliance mindset.
• Analytical thinking and problem-solving skills.
• The ability to work accurately and independently.
• A proactive and flexible attitude.
• An interest in both operational manufacturing support and documentation-based QA activities.
• Willingness to learn new processes and take ownership of quality-related responsibilities.
• Strong teamwork and communication skills.

Why join this company?
You will join an international biotechnology organization where innovation, quality and patient safety are central to daily operations. This role offers the opportunity to develop expertise in both clinical manufacturing and clinical supply chain quality assurance. You will receive structured training, work alongside experienced QA professionals and contribute directly to the quality and compliance of clinical trial products. The company offers a collaborative, international working environment with opportunities for professional development and long-term career growth.