Associated Director Quality Assurance - QP

Associate Director Quality Assurance - Qualified Person (IMP) Remote, Ireland
Life Science Consultancy Broad Client Portfolio IMP & Commercial Products

My client is an established and growing life science consultancy, rapidly expanding its footprint in Ireland. As part of this growth, they are seeking an experienced Qualified Person (QP) with extensive Investigational Medicinal Product (IMP) expertise to lead their quality function.

This is a senior leadership role offering the opportunity to work with a diverse range of life science companies - from start-ups to established global players - across a broad mix of pharmaceutical and biopharmaceutical products, including rare disease and gene therapies.

The role can be performed remotely from anywhere in Ireland and is focused on guiding clients' development products through to both European and global launches.

Key Responsibilities:

Provide expert guidance on EU Good Manufacturing and Distribution Practice (GMDP) both internally and to clients

Lead and develop the internal GMP and GDP Quality Teams

Act as a primary contact for current and prospective clients

Perform QP duties on the organisation's IE MIA / MIA-IMP licences and client MIAs as required

Experience & Qualifications:

Minimum 10 years' pharmaceutical industry experience with in-depth knowledge of quality systems in a GMP environment

At least 7 years of experience as a Qualified Person, eligible to be named on MIA/MIA-IMP licences

Demonstrable experience hosting GMDP regulatory inspections

Eligibility to act as a Responsible Person (RP) on a WDA(H) is desirable

Broad knowledge of GMDP requirements and IMP lifecycle from development to commercialisation

This is an excellent opportunity for an experienced QP to take a senior, strategic role within a highly regarded and expanding consultancy, with exposure to a wide range of products and clients.

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 1

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