Director, Clinical QA

5 days ago

San Francisco, California, United States Bluejay Therapeutics Full time $200,000 - $300,000 per year

Company Description

Bluejay Therapeutics
is a small private biotech company located in Redwood City, California. The company is
dedicated to developing innovative cures for infectious diseases, with a primary focus on chronic HDV infection. Our mission is to advance groundbreaking treatments and improve patient outcomes. We strive to make a significant impact on global health through our innovative therapeutic solutions.

Role Description

We are seeking an experienced
Director, Clinical QA / GCP
, to lead clinical quality across development-stage programs. This role ensures global Good Clinical Practice compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The role drives proactive risk identification and mitigation across the clinical development lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning.

Responsibilities:

Lead GCP quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations

  • Develop and support phase-appropriate Quality Management System (QMS) for clinical activities, including SOPs, training, document control, and vendor oversight
  • Oversee clinical quality activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance
  • Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters
  • Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA)
  • Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement
  • Partner with Regulatory Affairs to align quality and safety with regulatory strategy, i.e., experience with regulatory submissions

Qualifications:

  • BS or advanced degree in biology, chemistry, life sciences, or related field.
  • 10+ years in biotech/pharma, with 8+ years in clinical quality with preferred direct experience in clinical operations or similar clinical compliance role
  • Strong knowledge of GCP, domestic and global regulatory expectations
  • Experience supporting both early- and late-stage development programs
  • Demonstrated success with inspection readiness and direct interactions with health authorities, e.g. FDA BIMO
  • Foster transparent, positive communication and cross-functional collaboration.
  • Encourage adaptability and calculated risk-taking, modeling resilience through change.
  • Strong communication, collaboration, and leadership skills in a fast-paced, high-growth environment
  • Foster transparent, professional communication with internal and external stakeholders, at all levels
  • This is a hybrid on-site / remote work schedule, with 3 days on-site per week

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