Senior Director Clinical Quality Assurance

4 weeks ago

San Francisco, United States Meet Full time

We are partnering with an innovative biotech in the treatment of liver and cardio-metabolic diseases. They are looking to add a leader to their Quality Assurance team in one of their phase III trials.


Responsibilities:

  • Establish and maintain the GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
  • Act as the primary business partner with internal organizations including Clinical Operations and Clinical Development.
  • Act as the primary contact for vendors, contract facilities and contract service providers related to quality aspects of clinical trials.
  • Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities.
  • Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.
  • Responsible for writing and maintaining GCP SOPs and providing associated training.
  • Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.


Qualifications:

  • Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy).
  • 12 years of relevant biotechnology experience including 3+ years in an applicable Sr. Quality leadership role.
  • 8 years GCP Quality Assurance experience.
  • Experience in developing and maintaining QA systems.
  • Experience working with CROs
  • Knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities.

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