Senior associate QA (GMP)

Your new company

Join a leading global biopharmaceutical organisation dedicated to improving patients' lives through the development, manufacturing, and distribution of innovative healthcare products. The company operates in a highly regulated GMP environment and is committed to quality, compliance, and continuous improvement. This position is based within a dynamic production quality team, working closely with Production, Engineering, Warehouse, and Quality stakeholders.

Your new role

As a Senior Associate QA (GMP), you will provide Quality Assurance oversight for the supply chain of clinical trial products while supporting clinical packaging and labelling operations. You will collaborate with stakeholders across Global Clinical Supply Chain, Production, Warehouse & Distribution, Regulatory Affairs, Site Quality, and Clinical Research Management to ensure compliance with GMP, GDP, and regulatory requirements.

Key responsibilities include:

• Performing batch record review to support QP certification of Investigational Medicinal Products (IMPs).
• Reviewing and approving clinical label artwork for compliance with regulatory requirements.
• Assessing temperature excursions during transportation and storage of clinical products.
• Supporting investigations and resolution of quality and compliance issues related to manufacturing and distribution activities.
• Reviewing and approving minor deviations while ensuring procedural compliance.
• Creating, maintaining, and improving SOPs and work instructions.
• Reviewing procedures to ensure compliance with corporate, site, and regulatory requirements.
• Preparing and reporting monthly quality metrics.
• Identifying quality issues and driving solutions in collaboration with cross-functional teams.
• Providing QA support on the manufacturing floor, including pack checks, batch record review, issue handling, and QA compliance checks during clinical packaging and labelling operations.

What you'll need to succeed

• Master's degree in Life Sciences or a related scientific discipline.
• Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience.
• Experience with batch record review, investigations, deviations, and analytical testing.
• Strong knowledge of:
• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• Experience working in a regulated pharmaceutical, biotechnology, or medical device environment.
• Fluent English communication skills, both written and verbal.
• Strong attention to detail and compliance-focused mindset.
• Excellent problem-solving and analytical skills.
• Ability to build effective working relationships across multiple functions.
• Proactive attitude with a willingness to learn and take initiative.

What you'll get in return

Hays Detachering | This is a project that will start with a contract for 12 months through Hays. An extension to stay within the department is anticipated. In this position, you will get a competitive salary starting at €4200 bruto per month and your travel expenses are covered.