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Chief Quality Assurance Officer, Regulatory Compliance Specialist

1 month ago

Brisbane, Queensland, Australia Vera Therapeutics, Inc Full time
Job Overview

Vera Therapeutics, Inc. is a biotechnology company focused on developing treatments for serious immunological diseases.

We advance innovative solutions to change the standard of care for patients suffering from autoimmune diseases.

Our team seeks an experienced Chief Quality Assurance Officer to develop and maintain GMP, GLP, and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations and industry standards.

Key Responsibilities
  • Develop and implement quality management systems ensuring compliance with regulatory requirements and industry standards.
  • Assess and ensure quality and regulatory compliance related to Good Clinical Practices (GCPs), pharmacovigilance, Good Laboratory Practices (GLPs), and other relevant activities.
  • Provide quality assurance for GMP, GLP, and GCP environments, as well as document control.
  • Lead the investigation and resolution of Out of Specifications and Deviations.
  • Establish or develop policies and procedures for Good eXchange Practice (GxP) environments.
Requirements
  • Bachelor's degree or higher in biology, chemistry, or a related life sciences discipline.
  • At least 8 years of experience in quality assurance, including demonstrated leadership in a QA function.
  • Prior experience establishing, implementing, and administering quality systems, including Electronic Document Management Systems (EDMS).
  • Experience with Veeva Qdocs and QMS modules is advantageous.
Compensation Package

Anticipated base salary: $192,400 - $234,800 per year.

A competitive annual performance-based bonus and ongoing equity opportunities are available.

The compensation package includes comprehensive medical, dental, and vision insurance, a 401(k) match, flexible time off, and paid holidays.