NPI QA Specialist: New Product Transfers & Compliance Lead

SmartRecruiters, Inc.; Leinster; On-site; EUR 70,000 - 95,000; Full time

Job summary

AbbVie in Ireland seeks a Senior NPI Compliance Specialist to drive quality for NPIs, oversee transfers from development through commercialization, and liaise with local and cross-functional teams to ensure regulatory compliance. The role supports analytical method transfers, vendor evaluations, and QA documentation across the site.

Responsibilities include coordinating site reviews of material specifications, managing exceptions, preparing quality project deliverables, and supporting audits and

Qualifications

• 5 years’ experience in the healthcare / pharmaceutical industry.
• A minimum of 3 years experience in a Quality role.
• Being QP eligible is desirable.

Responsibilities

• Implement and maintain the integration of projects and NPIs into AbbVie’s quality system.
• Ensure projects at AbbVie North Dublin meet regulatory requirements and AbbVie procedures.
• Support new product transfers from development through commercialization, liaising with cross functional teams to address quality concerns.
• Support review and approval of NPI-related Analytical Test Method Transfers and validation.
• Coordinate vendor evaluation and approval, management of technical agreements from initiation to storage.
• Collaborate with internal and external stakeholders to maintain roles and responsibilities and identify quality issues.
• Coordinate review of new product material specifications (intermediates, API, drug product, excipients).
• Lead corrective and preventative actions to prevent recurrence and generate QA documentation.

Skills

Quality assurance

Regulatory compliance

NPI transfers

GxP compliance

Cross-functional teamwork

Job description

AbbVie in Ireland seeks a Senior NPI Compliance Specialist to drive quality for NPIs, oversee transfers from development through commercialization, and liaise with local and cross-functional teams to ensure regulatory compliance. The role supports analytical method transfers, vendor evaluations, and QA documentation across the site.

Responsibilities include coordinating site reviews of material specifications, managing exceptions, preparing quality project deliverables, and supporting audits and