Senior Auditor, Supplier Audit & Compliance
Core
Conduct comprehensive supplier quality assurance audits and compliance evaluations for AbbVie plants, affiliates, and suppliers to ensure adherence to US and foreign regulations (GMP) and maintain product safety and quality.
Role type
Senior Quality Assurance Auditor (Supplier & Compliance)
Builds
Supplier quality assurance audit reports, corrective action plans (CAPA), and compliance documentation for AbbVie's supply chain.
Domain
Pharmaceutical manufacturing and supply chain compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis (audit reports, CAPA tracking)
Required skills
Quality Assurance audit process, GMP regulations, corrective action management, stakeholder coordination, project management, technical background in science/engineering
Preferred skills
ASQ certification, experience in medical device/biologics/cosmetics industries
Technologies
None explicitly listed
Responsibilities
Assess compliance of systems, facilities, and procedures per applicable regulations; Provide feedback on audit observations and review corrective actions; Participate in strategic initiatives to improve regulatory compliance; Collaborate with R&D QA for joint audits; Coordinate supplier audit activities with internal and external stakeholders; Ensure audits follow the annual schedule; Prevent product launch delays or business interruptions due to audit issues.
Seniority
Senior, hands-on IC with strategic initiative participation