AbbVie este o companie farmaceutică globală axată pe descoperirea, dezvoltarea și furnizarea de medicamente pentru afecțiuni complexe. Portofoliul său acoperă imunologia, oncologia, neuroștiința și medicina estetică, iar operațiunile sale deservesc pacienți din peste 175 de țări. Activitatea companiei combină cercetarea farmaceutică, producția și expertiza în domeniul sănătății, susținute de investiții substanțiale în inovarea științifică și cercetare și dezvoltare. AbbVie pune, de asemenea, accent pe diversitate, sustenabilitate și sprijinirea pacienților, ca parte a abordării sale mai ample pentru îmbunătățirea rezultatelor în domeniul sănătății și a impactului asupra comunităților.
Senior Supplier Audit and Compliance Auditor
Lead supplier quality audits and regulatory compliance reviews for AbbVie’s medicines and healthcare products. Oversee external audits, corrective actions, and cross-functional GxP initiatives.
Descriere
- Audit third-party service providers and manufacturers against global quality and regulatory requirements
- Apply pharmaceutical, medical device, and regulated-study regulations, guidelines, policies, and procedures
- Plan and conduct independent supplier audits covering systems, facilities, and processes
- Document audit findings and assess corrective actions for implementation, effectiveness, and ongoing maintenance
- Help maintain the approved supplier list and global audit schedule
- Support supplier management activities, including Management Reviews and Supplier Change Notifications
- Train and advise audit colleagues and internal partners on GxP regulations and guidance
- Work with Inspection Management on audits conducted by regulators and customers
- Maintain and update departmental systems, procedures, and records
- Escalate issues to management when needed
- Lead cross-functional objectives and resolve project team issues with limited oversight
- Contribute to strategic efforts to strengthen regulatory compliance
- Plan and conduct joint audits with AbbVie Operations
- Keep audits aligned with the annual schedule
- Mentor colleagues and lead cross-functional teams
- Report to the Director of RDQA External Partners Quality Audit or their delegate
Cerințe
- Bachelor’s degree, preferably in a technical or scientific field such as chemistry, pharmacy, biology, microbiology, or engineering
- Demonstrated leadership ability
- Strong technical skills and ability to work independently
- A proven record of applying core and technical competencies
- At least 8 years of total experience, including 3 or more years in compliance or auditing
- Experience in pharmaceuticals, medical devices, biologics and combination products, cosmetics, eye care, or aesthetics
- Strong knowledge of international GMP and device regulations, including US FDA, EU, and MDR/IVDR standards
- Quality assurance auditing experience preferred
- Pharmaceutical or device manufacturing experience preferred
- An equivalent combination of education and experience may be accepted
- Professional accreditation is desirable, such as ASQ Certified Quality Manager (CQM) or Certified Quality Auditor (CQA)
Beneficii
- Remote work
- Equal opportunity employer
- Commitment to integrity, innovation, improving lives, and community service