Director, Quality Management – Translational Medicine Oncology

AstraZeneca
Gaithersburg, MD
Job Description
Role Overview

Join Early Oncology's Translational Medicine (TM) Global Operations team to drive quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations. As a key quality partner, you will advise on compliance and risk, lead continuous improvement, and champion a culture of quality excellence.

What You Will Do

Review, assess, and communicate the status of the Quality Management System (QMS) for TM and BST teams, provide firstline quality and compliance advice, conduct targeted self-inspections, and author quality SOPs.

Why It Might Be a Fit

This role requires significant pharmaceutical/biotech experience in Quality Assurance/Quality Management, strong working knowledge of ICH-GCP, and ability to operate independently in a matrix.

Requirements

  • Bachelor's degree in sciences (or equivalent practical experience)
  • 5+ years of relevant work experience
  • Significant pharmaceutical/biotech experience in Quality Assurance/Quality Management
  • Strong working knowledge of ICH-GCP, international regulations, and relevant quality guidelines

Benefits

  • Competitive Total Reward program
  • Market driven base salary
  • Bonus
  • Long term incentive
  • Paid time off program
  • Comprehensive benefits package
  • Qualified retirement programs
  • Health, dental, and vision coverage
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