Our Client is a global biotechnology company focused on discovering developing, and delivering high-quality medicines for people living with rare metabolic diseases.

The Position

• The client is seeking a Quality expert with a working knowledge of biopharmaceutical manufacturing, reporting to the Associate Director, External Quality Lead.
• The suitable individual will be the point of contact for communication between Amicus and the CMO, providing quality reviews of manufacturing batch records and associated supporting documentation for the production of clinical and commercial products.
• The person will be responsible for supporting departmental quality initiatives and maintaining Amicus Quality standards.

The Person

• BS or equivalent and a minimum of 3 years of experience in the pharmaceutical/biotech industry.
• Must have at least 1-year experience in the review and disposition of manufacturing batch records.
• Working knowledge of FDA and EMA GXP regulations and ICH guidance documents.
• Experience communicating with vendors in the dispositioning of batch records and quality events.
• Experience in the manufacture of biopharmaceutical drug substance and drug product.

The Benefits

• Competitive contracting rates for this role.
• Flexible working with a hybrid work-model adopted for this role.

To discover more about this opportunity please apply online or contact Darragh in HRM Search Partners on +353 879345234 for a confidential discussion.