Job Title: NPI QA Compliance Specialist
Location: Sligo, Ireland
Contract: 12-Months
Rate: €40 per hour
Overview
The NPI Compliance Specialist provides Quality Assurance oversight for New Product Introduction (NPI) from development through clinical and commercial manufacture. This role supports aseptic biologics manufacturing, ensuring full compliance with cGMP, regulatory requirements, and quality systems.
You will act as a key NPI Quality representative, partnering cross-functionally and engaging with external vendors and regulatory bodies, with a strong focus on embedding quality from first transfer to commercial readiness.
Key Responsibilities
- Provide Quality oversight for new product transfers (NPI) from development to commercial manufacture
- Ensure compliance with cGMP, regulatory standards, and site Quality Systems
- Support vendor qualification, supplier approval, and manage Quality/Technical Agreements (QTAs)
- Review and approve Analytical Test Method Transfers and method validation
- Coordinate approval of material specifications (raw materials, excipients, BDS, Drug Product)
- Support deviations, investigations, CAPAs, and product-related exceptions
- Generate and approve product transfer and stage-gate documentation
- Act as SME during internal audits and regulatory inspections
- Collaborate with QA, CMC, R&D, S&T, Operations, and external partners
- Maintain strong EHS compliance and promote a culture of safety excellence
Requirements – Essential
- Third-level qualification in Science, Quality, Engineering, or related discipline
- 3+ years’ experience in Quality Assurance supporting NPI / Tech Transfer
- Strong working knowledge of cGMP, regulatory compliance, and Quality Systems
- Proven experience in aseptic manufacturing, biologics, or sterile operations
- Experience with analytical methods, product start-up, and process transfer
- Ability to work independently, manage priorities, and drive issues to closure
Desirable
- 2+ years’ experience in an aseptic processing environment
- Exposure to biologics manufacturing, including antibody-drug conjugates (ADCs)
Key Skills & Competencies
- New Product Introduction (NPI)
- Quality Assurance / Quality Compliance
- Aseptic Manufacturing
- Tech Transfer / Start-Up
- Supplier & Vendor Management
- CAPA / Deviations / Investigations
- Regulatory Inspections & Audits
- Cross-functional collaboration
- Right First Time mindset
Manufacturing Environment
- Aseptic filling operations across multiple fill lines
- Biologics drug product manufacturing, including ADC processes
Eligibility
Only candidates with a valid Irish work visa or EU passport will be considered.
To discuss this role confidentially:
Contact Corné on 094 9316002 or [email protected]
IND005
Job Type: Full-time
Pay: €40.00-€45.00 per hour
Ability to commute/relocate:
- Sligo, County Sligo: reliably commute or plan to relocate before starting work (required)
Work authorisation:
Work Location: In person
