Director, Clinical Quality Assurance in Berkeley, California at RAY THERAPEUTICS INC
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Job Description
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 management plans, and other GCP-critical documents to verify compliance with GCP requirements
- Review and negotiate Quality Agreements with CROs and external service providers
- Ensure trial master file (TMF) completeness and inspection-readiness
- Lead GCP audit program, including audit planning, execution, report writing, and escalation of critical findings
- Own clinical QA SOPs and associated documentation, ensuring alignment with GCP requirements, company QMS, and evolving industry best practices
- Oversee deviation and non-conformance management for clinical activities, driving thorough root cause investigations and robust CAPA plans
- Lead GCP training strategy and program for clinical staff, investigators, and site personnel
- Establish and report clinical quality metrics and key performance indicators (KPIs) to senior leadership and at management review
- Support preparation of risk-benefit communications and quality-related clinical narratives for agency interactions
- Champion a culture of quality and patient safety through cross-functional education, proactive risk identification, and constructive engagement with internal and external stakeholders
Qualifications and Experience:
- Bachelors degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 10 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry.
- Deep expertise in GCP regulations and guidelines. Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
- Demonstrated experience conducting and managing clinical site audits, CRO audits, and internal GCP audits
- Strong written and verbal communication skills, including the ability to distill complex compliance topics for varied audiences
- Ability to travel 10-20% based on business needs
Compensation Range and Benefits:
- For this role, the anticipated base salary range: $195,000 to $215,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
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