Prothena

Associate Director, Clinical QA

US-CA-South San Francisco
Job ID
2017-1220
Category
Research & Development

Overview

The Clinical Quality Assurance (CQA) function is an essential part of Prothena’s Quality Assurance Department ensuring that clinical trials are in compliance with Good Clinical Practices.  This position will be responsible for maintaining quality systems, procedures, and documentation in compliance with applicable US and international standards/regulations. 

Responsibilities

  • Responsible for planning, conducting and/or overseeing the audit execution and reporting on Prothena studies in accordance with Good Clinical Practice (GCP) standards, and local and federal regulations for:
  • Contract service providers (Contract Research Organizations, central laboratories, core/specialty laboratories, etc.)
  • Clinical investigational sites
  • Schedule and conduct internal CQA/GCP systems and study audits (i.e. clinical data listings, study reports, and associated clinical and regulatory documents, etc.)
  • Track and follow-up on audit findings/corrective actions until closure
  • Serve as CQA study team representative for assigned Prothena studies
  • Maintain and report CQA metrics to (C)QA management and other Clinical department stakeholders, as requested
  • Identify, develop and assist in GCP training to Clinical Departments and clinical investigators and study monitors, as requested
  • Act as a resource to the Clinical Departments on GCP and/or quality assurance issues
  • Conduct a Quality Assurance review of clinical study reports and audit trial master files for applicable regulatory compliance
  • Provide compliance support during regulatory inspections of the company, investigational sites or potential partners, as applicable
  • Develop, review, and implement SOPs relating to GCP, as needed
  • Stay abreast of changes in applicable FDA and European regulations, directive and guidelines and determine its impact on company studies
  • Travel 15% - 25%, as requested
  • Other duties as assigned

Qualifications

Education and/or Experience:

  • Bachelor’s degree in health science or medical field, or equivalent
  • 10+ years of experience in the pharmaceutical or biotechnology industry, 5+ years of experience with auditing of clinical trials and associated documentation
  • Strong understanding of applicable regulatory requirements and ICH Guidelines
  • Knowledge of GPVP/GLP preferred
  • Certified Quality Auditor (CQA) certification preferred

Competencies and Attributes:

  • Demonstrates ability to obtain results needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Excellent communication skills
  • Excellent interpersonal and collaborative skills

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