Job Description

The Opportunity:   Clinical Quality Assurance Consultant - GCP

Seeking a contractor, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing compliance support for sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

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  Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
  
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  Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
  
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  Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
  
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  Collaborate with internal stakeholders, internal or external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
  
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  Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
  
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  Provide support for Inspection Readiness activities.
  
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  Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, root cause analysis, CAPA planning and management.
  
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  Escalate identified issues to QA Management as needed.
  
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  Enable other assigned GCP or GXP-related tasks, as appropriate.
  
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  Support GCP audits and inspections of, Vendors, and clinical investigator sites by regulatory authorities or business partners.
  

Required Skills, Experience and Education:

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  Bachelor’s degree in a scientific or technical discipline.
  
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  A minimum of 12 years of experience in GCP Quality in the pharmaceutical or biotechnology industry
  
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  12 years in the following areas: audit/audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
  
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  Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (FDA, EMA) regarding applicable drug development regulations.
  
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  Effective communication (verbal and written).
  
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  Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
  
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  Ability to critically evaluate and troubleshoot complex problems with diligence.
  
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  Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
  

Preferred Skills:

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  Good knowledge of Computer System Validation.
  

Job Tags

Remote job, Contract work, For contractors,

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