Location: Leiden/Sassenheim, Netherlands

Department: Quality Assurance

Employment Type: 1 years of contract with possible contract to hire/Extension

Job Overview

We are seeking a highly skilled QA Specialist to provide quality oversight for Advanced Therapy (AT) manufacturing operations at our Leiden/Sassenheim site. This role serves as the primary QA point of contact for Drug Substance production and quality control activities, ensuring compliance with cGMP and regulatory standards (FDA, EMA, ICH).

Functie-eisen

Lead QA activities for AT manufacturing and QC operations.
Provide oversight on deviations, CAPAs, change control, validation, and audits.
Review and approve GMP documentation, protocols, and investigations.
Support regulatory inspection readiness and represent QA during audits.
Deliver GMP training and foster a culture of quality and compliance.
Participate in cross-functional projects and continuous improvement initiatives.

Competenties

Bachelor’s or Master’s in Biochemistry, Biology, or a related field.
4–6+ years of experience in a GMP-regulated environment (QA, QC, or Manufacturing).
Strong knowledge of GMP regulations (FDA, EMA, ICH).
Excellent communication, decision-making, and problem-solving skills.
Fluent in English (spoken and written).

Arbeidsvoorwaarden

What We Offer:

Be part of a team dedicated to advancing healthcare and improving lives.
Work in a collaborative, safety-focused environment with cutting-edge equipment.
Opportunities for professional growth, training, and development.
Competitive salary and benefits package.

Bedrijfsinformatie

Apply today to become a key contributor in maintaining the integrity and reliability of equipment that shapes the future of medical innovation.

Why YACHT?

Because of challenging positions at leading companies, a large network and development opportunities! These are the advantages of working via YACHT.

With us, you will get all the space to grow further. Together we will look for assignments that suit your ambitions and help you to realize your goals. Through coaching, for example, but also by inviting you to interesting courses, knowledge sessions and inspiring meetings.

Through us, you will get access to a large network of professionals and companies that are happy to share their knowledge and opportunities with you.

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.

contact

Sowmya Kandukuri
sowmya.kandukuri@yacht.nl
+918374294984

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