Associate Director Quality Assurance - QP
Based in Ireland with Remote/Hybrid Working Options
My client is an established and growing life science consultancy, rapidly expanding its footprint in Ireland. As part of its 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 organization’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 00 353 1 6498546
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation positions.
Applications are in strict confidence.
Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website.
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance, Production, and Product Management
Industries: Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr