AbbVie
AbbVie
AbbVie — күрделі денсаулық жағдайларына арналған дәрі-дәрмектерді ашуға, әзірлеуге және ұсынуға бағытталған жаһандық фармацевтикалық компания. Оның портфелі иммунология, онкология, неврология және эстетика салаларын қамтиды, ал қызметі 175-тен астам елдегі пациенттерге көрсетіледі. Компанияның жұмысы фармацевтикалық зерттеулерді, өндірісті және денсаулық сақтау саласындағы тәжірибені біріктіреді әрі ғылыми инновациялар мен зерттеулерге және әзірлемелерге қомақты инвестициялар арқылы қолдау табады. AbbVie денсаулық нәтижелері мен қоғамға әсерді жақсартуға бағытталған кең ауқымды тәсілінің бір бөлігі ретінде әртүрлілікті, тұрақты дамуды және пациенттерді қолдауды да атап көрсетеді.

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.

Сипаттама

  • 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.

Талаптар

  • 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.

Артықшылықтар

  • 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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