Senior NPI Compliance Specialist, Sligo

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.

• Third-level qualification in science, quality, or a related discipline.
• Minimum of 5 years’ experience in a quality role supporting new product introductions.
• Preferred: QP eligible, or actively working toward QP eligibility, with an interest in pursuing Qualified Person status in the future.
• Strong knowledge of regulatory requirements.
• Excellent attention to detail, problem-solving, and decision-making skills.
• Strong communication, interpersonal, and collaboration skills.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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