Director, Clinical Quality Assurance

Job Description

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 is a high-impact, hands-on role for a deeply experienced GCP professional who brings expert-level knowledge of clinical trial quality and a strong command of the unique regulatory complexities surrounding advanced therapy medicinal products. 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 Director will be instrumental in establishing clinical QA infrastructure — authoring and updating SOPs, executing audit programs, driving inspection readiness, and ensuring data integrity and patient safety across all clinical activities.

The role is based in the Berkeley, CA office with a hybrid 3 days per week in office requirement.

Essential Duties and Responsibilities:

• Serve as the primary QA point of contact for clinical trial activities, partnering closely with Clinical Operations and Data Management functions
• Review and approve clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), risk management plans, and other GCP-critical documents
• 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:

• Minimum bachelors degree in relevant scientific discipline
• 10+ years of progressive quality assurance experience in the biopharmaceutical or pharmaceutical industry, with at least 5 years specifically in GCP/Clinical QA
• Deep expertise in GCP regulations and guidelines
• 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

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $175,000 to $195,000, 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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