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Remote RDQA Clinical Quality Auditor — New Jersey

Conduct GCP audits and corrective-action follow-up for AbbVie, supporting clinical quality and compliance across global operations. Advise business partners on clinical regulations, quality systems, and inspection readiness.

USStatele Unite ale AmericiiNJNew JerseyRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăAuditor
Google Cloud Platform

Descriere

  • Manage the Clinical audit program, including scheduling, planning, reporting, and audit resolution.
  • Maintain alignment 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 quality-assurance oversight to verify compliance.
  • Lead and support the scheduling, planning, and execution of Clinical audits.
  • Perform investigator site, process, system, and Affiliate audits.
  • Deliver oral and written audit results 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.
  • Support the maintenance and development of quality standards for Clinical audits.
  • Participate in continuous-improvement initiatives and projects.
  • Support GCP inspections as needed.
  • Provide GCP regulatory guidance and consultation to RDQA and business partners.
  • Encourage ongoing education in 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 and skill in drawing conclusions from presented data.
  • Capacity to work effectively and efficiently in a dynamic environment with minimal supervision.
  • Working awareness of clinical-trial regulations, including ICH-GCP and the EU Clinical Trial Directive/Regulation, as well as industry best practices.
  • Flexibility to adapt to changing assignments and prioritize work effectively.
  • Strong project-management, interpersonal, and communication skills.
  • Ability to work independently and collaboratively within a team.
  • Willingness and ability to travel internationally.
  • Availability for travel of up to 40%.
  • Equivalent experience may be accepted in place of the stated bachelor’s degree.

Beneficii

  • Paid time off, including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance.
  • 401(k) plan.
  • Short-term incentive programs.
  • Equal-opportunity employer benefits and reasonable-accommodation support for eligible applicants.

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