Associate Director of Validation

This Biologics operation has a strong diverse product portfolio and who has its Headquarter based here in Ireland.

This Associate Director of Validation role is joining a strong international team that oversees the GMP, Tech Transfer and Validation for the entire product portfolio. The role will required a strong experience individual who will have the ability to accommodate an element of travel, and who has an understanding/experience with a Biologics operation.

Key Responsibilities

• To lead all the Validation processes across the business, including both company manufacturing operations and outsources partners
• Work very closely with outsourced partners on an ongoing basis to ensure standards are established and maintained
• Drive forward the organisations Validation strategy, while consistently seeking areas to strengthen and enhance the strategy
• Work with different divisions on the Validation frameworks, from the clinical stage right through to commercialisation, to ensure all requirements and regulations are met
• Be an expert on all relevant regulations, both existing and upcoming, to ensure strong Validation processes
• Provide strong Validation advice and support to many areas within the business when needed
• Work with product development teams to guide from a Validation perspective
• Participate in audits when needed

Requirements:

• Strong experience at a similar level, in a Validation role is essential
• Experience dealing with internal and external manufacturing operations is heavily desired
• Experience leading teams is essential
• Masters level education in a relevant field is desired

The Next Step for you:

Should this position be of interest to you please forward your CV to Luke Davis from Next Generation Recruitment or alternatively call on the main line.

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Applications are in strict confidence. Next Generation emphatically stresses, that as an organisation, will not forward your CV or any other personal details to any 3rd parties without your full prior approval.