Director of Quality Operations

1 month ago


San Francisco, California, United States Pliant Therapeutics Full time
Job Title: Director of Quality Operations

Pliant Therapeutics is a leading biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. As a Director of Quality Operations, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:
  • Provide strategic leadership and oversight of internal and external quality operations
  • Ensure compliance with cGMP regulations, ICH, FDA, and EU regulations
  • Develop and implement quality systems, including disposition, vendor management, deviations, change control, and CAPA
  • Lead batch disposition activities and support commercialization
  • Collaborate with cross-functional teams to ensure quality and compliance
Requirements:
  • 12+ years of experience in pharmaceutical or biotechnology industry cGMP experience
  • At least 10+ years of experience in positions of management responsibility within Quality Assurance
  • Strong knowledge of cGMP, ICH, FDA, and EU regulations
  • Direct experience working with CSPs within the US and globally
  • Prior global commercial experience, including process validation and technology transfer
What We Offer:
  • Competitive annual base salary: $225K - $235K
  • Benefits, equity, and annual target bonus for full-time positions
  • Opportunity to work with a leading biopharmaceutical company

Pliant Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment.



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