Job Title: Quality Director
About the Role:
We are seeking an experienced Quality Director to join our team in Dublin on a 12-month contract. As a key member of the team, you will provide scientific and regulatory leadership across assets, with responsibilities spanning analytical methods, specifications, reference standards, and comparability approaches.
Main Responsibilities:
* Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialisation.
* Provide scientific expertise in the lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.
* Serve as a subject-matter expert in analytical sciences, advising on cross-functional matrix teams and ensuring alignment with regulatory expectations.
Required Skills and Qualifications:
* A Ph D, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within an analytical CMC / relevant field.
* Extensive knowledge and hands-on experience in analytical CMC for biologics, including specification setting, analytical comparability strategy and risk assessments, method lifecycle and change control, and reference standard strategy.
* Proven track record of independently authoring complex regulatory and scientific documents, such as justification of Specifications, analytical comparability protocols/reports, scientific briefing packages, responses to health authority questions.
What We Offer:
* An opportunity to work with a leading Biopharmaceutical client.
* A dynamic and collaborative work environment.
* The chance to develop your skills and expertise in analytical CMC.
Contact Us: