Quality Assurance Manager - GCP

Reporting Line: Director, Quality Assurance
                                               

Purpose of Position

The incumbent will oversee the development, implementation and maintenance of quality assurance systems and activities. Oversees generation and review of documents used in good clinical practices (GCP). Maintains oversight of all clinical vendors and will complete audits as directed.  Works with the Clinical Operations team to ensure inspection readiness. Coordinates interdepartmental activities.  May lead investigations and resolve potential GCP quality issues to ensure protocol compliance, protect subject safety and data integrity.
Roles & Responsibilities:
  • Provide GCP compliance oversight of internal systems and processes as well as those of CROs, vendors, and clinical investigator sites.
  • Plans and conducts internal GCP audits. Manages all audit findings and resulting CAPAs.
  • Completes clinical site audits and vendor audits and manages all resulting CAPAs
  • Coordinate the continuous improvement of systems to assure the quality of trials
  • Develops QA procedures for the GCP Quality Management System and educates staff on its function and importance
  • Establishes metrics for the Quality Management System to identify trends
  • Contributes to the preparation of Management Review reports
  • Provide input on all procedures to ensure compliance with applicable GCP and ICH regulations (E6(R2))
  • Provide GCP training to staff, as required.
  • Participates in the QMC as required and has oversight of the document management system and training records.
  • Leads all departments to ensure Aurinia and its CRO/clinical sites are in a state of inspection readiness, particularly as related to activities associated with Pre-Approval Inspections.
  • Identifies and monitors deviations and leads the CAPA management process for GCP issues.
  • Prepares QA memos, devotions or NTF for GCP issues as required.
  • Completes required SOP training as identified by in training matrix
  • Follows approved policies, SOPS and work instructions as written
  • Attends all required training sessions and obtains a passing grade to demonstrate effectiveness of training.
  • Ensures that QA GCP duties are carried out promptly, effectively and efficiently
  • Other duties as identified/assigned by management
Requirements:
  • University degree in science or college diploma, combined with a minimum of 8 years of relevant experience in the pharmaceutical industry
  • Minimum of three (3) years in a supervisory/management role
  • Excellent knowledge of Good Clinical Practices (GCP) and technical knowledge of pharmaceutical processes, as well as of quality control and quality assurance concepts
  • Knowledge of the international guidance’s and requirements (ICH, FDA, EMEA)
  • Experience in regulatory affairs would be an asset
  • Excellent command of English language both written and spoken
  • Knowledge of Microsoft applications
  • Attention to detail and follow through 
  • Ability to work independently as well as in a team environment 
  • Motivated with an ability to make quick, informed decisions 
  • Approximately 20% travel is required
  • Well-organized, able to multi-task and coordinate several projects at once

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc