AbbVie is seeking a Senior NPI Compliance Specialist to support the compliant transfer of new products to AbbVie Sligo for a fixed-term contract of 12 months. The role ensures products are manufactured in line with regulatory requirements, AbbVie procedures, and quality standards, working closely with cross-functional teams from development through commercialisation.

Responsibilities

• Maintain the effectiveness of the new product integration within the NPI quality system.
• Ensure new products meet applicable regulatory requirements and AbbVie policies.
• Support product transfers from development through commercialisation, including quality risk assessment and mitigation.
• Manage vendor evaluation and approval, including technical agreements.
• Review and approve NPI-related analytical test method transfers and/or validation.
• Collaborate with CMC QA, R&D, S&T, and other functions on quality issues and compliance inputs.
• Coordinate review of product-related material specifications, including API, drug product, raw material, excipient, and intermediate specifications.
• Support exception documentation and CAPA actions to prevent recurrence.
• Prepare product transfer documentation for stage gate reviews.
• Act as a subject matter expert during internal audits and external regulatory inspections.