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AbbVie
AbbVie
Sponsor pentru viza H1BAsistență medicalăConsultanțăIndustria prelucrătoare
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.
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Clinical Quality Auditor (RDQA) - Remote in Illinois

AbbVie is seeking a Clinical Quality Auditor to conduct GCP audits, oversee corrective actions, and support global clinical quality systems. The role helps maintain regulatory compliance and quality standards across clinical operations.

USStatele Unite ale AmericiiILIllinois
84.500 $ – 162.000 $ / an
RemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăAuditor
Google Cloud Platform

Descriere

  • Manage the Clinical audit program from scheduling and planning through reporting and issue resolution.
  • Maintain compliance with RDQA policies and procedures.
  • Help develop and implement the Clinical QA quality system.
  • Advise business partners on GCP and clinical quality matters.
  • Assess Clinical processes through audits and QA oversight for quality and compliance.
  • Lead and support Clinical Audit scheduling, planning, and execution.
  • Perform investigator site, process, system, and Affiliate audits.
  • Deliver audit findings verbally and in writing within established timelines.
  • Review and approve Corrective Action Plans and monitor actions through completion.
  • Help develop and implement systems and processes that support global quality assurance requirements.
  • Maintain or develop quality standards related to Clinical audit activities.
  • Support continuous improvement initiatives and projects.
  • Participate in and support GCP inspections when required.
  • Provide RDQA and business partners with guidance on GCP regulations.
  • Encourage ongoing education on quality, clinical guidelines, and regulations.

Cerințe

  • Bachelor’s degree in a physical, life, or health science; a healthcare profession such as nursing or pharmacy; or equivalent experience.
  • Three to five years of experience in the biopharmaceutical industry or with a regulatory authority.
  • Three to five years of experience in Quality Assurance and/or Clinical Research Development.
  • Strong analytical ability, including drawing conclusions from available data.
  • Ability to work efficiently in a changing environment with limited supervision.
  • Working knowledge of clinical trial regulations, including ICH-GCP and the EU Clinical Trial Directive/Regulation.
  • Understanding of industry best practices.
  • Adaptability to changing assignments and effective prioritization skills.
  • Strong project management, interpersonal, and communication abilities.
  • Capacity to work both independently and collaboratively.
  • Willingness and ability to travel internationally.

Beneficii

  • Paid vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • Short-term incentive programs.
  • Opportunities for international travel.

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