Day One Biopharmaceuticals is hiring a
Director GCP Quality Operations

Summary

The Director, GCP Quality Operations Lead will provide leadership in GCP, global regulations, and industry best practices at Day One Biopharmaceuticals. The role involves ensuring patient safety, data integrity, and compliance across partnerships and providing assurance of quality and compliance issues. The position is remote with occasional travel.

Requirements

• Bachelor’s degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred
• 10+ years R&D experience or relevant experience in science and clinical research, ideally with supporting clinical/regulatory/medical affairs, quality management, translational sciences, clinical development; equivalent experience
• 10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience

Responsibilities

• Provide expertise and leadership in the areas of Good Clinical Practice Regulations (GCP), global regulations, and industry standard best practices
• Ensure patient safety and data integrity
• Support the Senior Director, GCP Quality Assurance in the execution of the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement
• Represent GCP/GLP/GVP Quality and Compliance interests in the GCP vendor and systems assessment process

Benefits

• The salary range for this position is $220,000 - $230,000
• Day One Biopharmaceuticals offers competitive benefits. Please visit https://www.dayonebio.com/benefits to see the details