Clinical Trial Data Analyst

We are looking for a Senior QC Materials Specialist (Fulltime, 40 hours a week) to join our Akkodis team. 

Start: A.S.A.P.

Duration: Initially 6 months 

Deadline to apply: 21/07/2025 

Job summary

Join us as a Senior QC Materials Specialist, where you'll play a pivotal role in ensuring the availability, qualification, and compliance of critical materials that support the manufacturing and testing of life-changing therapies. Reporting into the Global QC Sciences team, you’ll work autonomously while collaborating cross-functionally to establish and maintain the global strategy for raw materials, reagents, reference standards, and assay controls within a GMP-regulated environment.

This is an opportunity to directly impact product quality, regulatory compliance, and the timely delivery of therapies to patients around the world.

Main tasks

• Lead the implementation and lifecycle management of critical raw materials, reagents, reference materials (including international reference standards), and assay controls in alignment with QC strategy.
• Define and oversee material qualification requirements, specifications, and incoming testing protocols to ensure consistency across global sites.
• Develop and maintain GMP-compliant documentation, including Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Guide the selection, qualification, and ongoing monitoring of reference standards and assay controls, including the design of bridging and comparability studies where necessary.
• Proactively identify and mitigate risks related to material readiness, assay performance, and regulatory expectations.
• Collaborate closely with cross-functional teams such as Analytical Development, QC, QA, Product Quality, Regulatory Affairs, Supply Chain, and Procurement to ensure alignment on material needs and timelines.
• Drive continuous improvement in material management practices to support operational excellence and compliance.

Welkom bij Akkodis

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.

We have +/- 60 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! 

Kandidaat Profiel

Job requirements:

• Bachelor’s or Master’s degree in a relevant scientific discipline.
• Minimum of 5 years’ experience in the pharmaceutical or biotech industry, preferably within a GMP-regulated QC environment.
• Strong expertise in the management and qualification of critical raw materials, reagents, reference standards, and assay controls.
• Hands-on experience with material risk assessments, change control processes, and GMP documentation.
• Familiarity with biologics, cell therapy, or advanced therapeutic modalities is a strong plus.
• Working knowledge of mammalian cell culture is advantageous.
• In-depth understanding of global regulatory requirements for material qualification and QC testing.
• Self-starter with excellent problem-solving skills and the ability to work independently while engaging a wide range of stakeholders.
• Exceptional technical writing and communication skills.
• A proactive, solution-driven mindset with a strong focus on quality, compliance, and execution.

Apply via your Talent Acquisition Specialist and/or send your CV to lifesciences@akkodisgroup.com.