Senior Specialist, Quality Systems

Ray Therapeutics mission is to restore vision to people with retinal degenerations. Ray Therapeutics 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 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 highly motivated and detail oriented Senior Specialist, Quality Systems to join our team in the mission to restore vision to patients. This role will report to the VP Quality Assurance and Compliance and will be responsible for maintenance and continuous improvement of our Quality Management System (QMS). The individual will work cross functionally with internal CMC, clinical, and regulatory teams and will support document control, training, CAPA, deviation management, supplier quality, and audit readiness.

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

• Administer the electronic Quality Management System including document control, training records, and workflow management
• Manage the GxP training program including curriculum development, assigning, and tracking
• Coordinate onboarding training for new hires
• Administer change control, deviation, and CAPA processes
• Collaborate with cross-functional stakeholders to ensure changes are documented, assessed and approved
• Support qualification and ongoing oversight of critical suppliers, maintain the GxP supplier list and coordinate supplier audits and questionnaires
• Prepare quality metrics for management review
• Assist with product complaint handling
• Generation and update of product specifications, SOPs, templates, forms

• Minimum bachelors degree in relevant scientific discipline
• 5+ years experience in a clinical-phase biotech environment
• Hands-on experience with document control, training management, change/deviation management
• Strong written and verbal communication skills with the ability to author clear,concise quality documents
• Highly organized, detail-oriented, and able to manage multiple priorities simultaneously in a small-team environment

• For this role, the anticipated base salary range: $120,000 to $140,000, 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.