Senior NPI Compliance Specialist
AbbVie View all jobs
- Sligo
- Contract
- Full-time
- 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.