Senior Director Clinical Quality Assurance
3 weeks ago
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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