Senior Manager, GCP Auditing (Remote)

The Denali Senior Manager of GCP Auditing, reporting to the director of Development Quality, is responsible for implementing Denali’s risk-based audit program. This role will drive all strategic and logistical aspects of GCP, GVP, and GCLP audits to ensure compliance with internal standards and procedures, global regulatory guidelines, and contractual agreements.

Denali is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven, risk-based decision making in a deadline driven environment.

Primary responsibilities

  • Independently define the scope, schedule, and provide support for the successful execution of GCP, GCLP and GVP audits across multiple global regions.
  • Participate as a co-auditor as required
  • Partner with Denali’s study teams to gather information to define targeted and clear audit objectives
  • Issue timely audit reports, audit observations, and oversee audit response process and drive audits to closure
  • Maintain meticulous audit documentation
  • Provide analysis of findings, track and trend information, incorporate root cause analyses and identify lessons learned for continuous improvement
  • Communicate audit information and outcomes to Denali’s study teams, Quality, and senior management
  • Educate, guide and influence internal and external partners on best quality and compliance policy and practices
  • Partner with rest of Quality department to develop, implement and assess clinical quality assurance strategies, organizational and operational needs
  • Identify and maintain audit metrics as a part of the Quality Management System
  • Support inspections as assigned

Qualifications and Experience

  • Passion for QA’s role in improving clinical programs and ensuring safe and effective therapies for patients
  • Demonstrated expertise and technical knowledge of GCP auditing, with a minimum of 3 years in clinical quality auditing or inspection management, and/or 6 years in a GCP related QA setting
  • GCLP and/or GLP QA experience is strongly preferred, with an understanding of clinical laboratory assessments and standards
  • Able to apply knowledge of, and interpret, ICH E6 (R2) GCP guidelines, and other worldwide clinical research regulations
  • Working knowledge of GVP annex IV is a plus
  • Stays abreast of auditing best practices in the industry
  • Able to build and maintain strong working relationships within Denali and Denali’s auditing network
  • Experienced at building and improving standards and process
  • Excellent verbal and written communication
  • Work according to procedures, guidelines and regulations, and within QMS framework
  • Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving
  • Able to work across multiple projects and prioritize tasks as required
  • Approximately 15% travel anticipated, depending on location of candidate

 

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