Senior NPI Compliance Specialist

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.

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