Posted: 18 June
The role
NPI Compliance Specialist
Location: Sligo, Ireland
Contract: 12 Months
Rate: Up to €45/hour
Ref: DES-1155
We are currently recruiting for an NPI Compliance Specialist to join a leading biopharmaceutical manufacturer in Sligo. This role will provide Quality Assurance oversight for New Product Introduction (NPI) activities, supporting products from development through to clinical and commercial manufacture within a highly regulated aseptic biologics environment.
Key Responsibilities
Provide QA oversight for NPI and product transfer activities from development to commercial manufacture
Ensure compliance with cGMP requirements, regulatory standards, and site Quality Systems
Support supplier qualification, vendor approval, and Quality Technical Agreements (QTAs)
Review and approve analytical method transfers, method validations, and material specifications
Support deviations, investigations, CAPAs, and product-related quality events
Generate and approve product transfer documentation and stage-gate deliverables
Act as a Subject Matter Expert during audits and regulatory inspections
Collaborate with QA, Operations, R&D, Technical Services, Supply Chain, and external partners
Requirements
Third-level qualification in Science, Engineering, Quality, or a related discipline
Minimum 3 years' experience in a Quality role supporting NPI, Tech Transfer, or Product Transfers
Strong knowledge of cGMP regulations and Quality Systems
Experience within aseptic manufacturing, biologics, or sterile operations
Experience supporting analytical methods, product start-up activities, and process transfers
Ability to work independently and manage multiple priorities
Desirable
Experience in an aseptic processing environment
Exposure to biologics manufacturing, including antibody-drug conjugates (ADCs)
To be considered, candidates must hold a valid Irish work permit or an EU passport.
For a confidential discussion, contact Corné on 094 9316002 or email corne@dillones.ie
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