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AbbVie
AbbVie
H1B vīzas sponsorsKonsultācijasRažošanaVeselības aprūpe
AbbVie ir globāls farmācijas uzņēmums, kas koncentrējas uz zāļu atklāšanu, izstrādi un piegādi sarežģītu veselības traucējumu ārstēšanai. Tā produktu portfelis aptver imunoloģiju, onkoloģiju, neirozinātni un estētiku, un uzņēmums darbojas vairāk nekā 175 valstīs, nodrošinot pakalpojumus pacientiem visā pasaulē. Uzņēmuma darbība apvieno farmācijas pētniecību, ražošanu un veselības aprūpes kompetenci, ko papildina ievērojamas investīcijas zinātniskajās inovācijās, pētniecībā un izstrādē. AbbVie savā plašākajā pieejā veselības rezultātu un ietekmes uz kopienām uzlabošanai izceļ arī daudzveidību, ilgtspēju un pacientu atbalstu.
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Vakances uzņēmumā

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.

CNĶīnaAttālinātiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuRevidents

Apraksts

  • 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

Prasības

  • 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)

Priekšrocības

  • Remote work
  • Equal opportunity employer
  • Commitment to integrity, innovation, improving lives, and community service

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