Senior NPI Compliance Specialist

Abb Vie is seeking a Senior NPI Compliance Specialist to support the compliant transfer of new products to Abb Vie Sligo for a fixed-term contract of 12 months. The role ensures products are manufactured in line with regulatory requirements, Abb Vie 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 Abb Vie 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.

Abb Vie 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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