QA Manager - Biologics

An established global pharmaceutical with multiple global manufacturing facilities have recently established a virtual global supply chain and have recently launched and developed multiple branded products . As part of this new external manufacturing structure they are currently developing a pipe-line of innovator products in bio-pharma and they need to hire a Quality Assurance manager as part of a new technical team.  

• You will report into a Global Director of Quality Assurance and be focused on quality operations across all biological products at all stages of development.
• You will work closely with both clinical and contract manufacturers across all aspect of quality assurance as products are being developed and launched.
• You will serve as quality assurance support and SME for development and Drug Substance, Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant.
• You will lead all quality risk management programs both internally and with external suppliers.
• You will Provide the requisite quality support to the regulatory/CMC group in support of licensee applications
• You will be degree qualified with 8-10 years quality assurance within the pharmaceutical or biopharma sector.
• You will have extensive drug product and drug substance experience

.The Next Step for you: 

Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120

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