Director, Clinical Quality Assurance

Skip to main content Director, Clinical Quality Assurance Ray Therapeutics, Inc. San Francisco Bay Area Apply Join or sign in to find your next job Join to apply for the Director, Clinical Quality Assurance role at Ray Therapeutics, Inc. Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. Director, Clinical Quality Assurance Ray Therapeutics, Inc. San Francisco Bay Area 11 hours ago Be among the first 25 applicants See who Ray Therapeutics, Inc. has hired for this role Apply Join or sign in to find your next job Join to apply for the Director, Clinical Quality Assurance role at Ray Therapeutics, Inc. Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. Save Report this job Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications. We are currently seeking a Director of Clinical Quality Assurance to serve as the senior individual contributor anchoring our clinical QA function. This role is responsible for leading the development, implementation and maintenance of QA systems and quality oversight of GCP operations. This role will ensure clinical trials are conducted with appropriate regulations, guidelines, procedures and protocols. Reporting to the Head of Quality, the Clinical QA Director will serve as a GCP subject matter expert and quality partner to Clinical Operations, Regulatory Affairs, and external clinical collaborators.The role is based in the Berkeley, CA office with a hybrid 3 days per week in office requirement.Essential Duties and Responsibilities:Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws.Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.Review and approve clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), risk...