{"schemaVersion":"jobsearcher.job.v1","id":"e1ecd44729c6c7d413332bdc","url":"https://jobsearcher.com/jobs/e1ecd44729c6c7d413332bdc","canonicalUrl":"https://jobsearcher.com/jobs/e1ecd44729c6c7d413332bdc","title":"Senior Specialist, Quality Systems","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\n\nSenior Specialist, Quality Systems\nFull Time, Berkeley, CA, US\n\nRay 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 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.\n\nWe 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.\n\nEssential Duties and Responsibilities:\n\nAdminister the electronic Quality Management System including document control, training records, and workflow management\n\nManage the GxP training program including curriculum development, assigning, and tracking\n\nCoordinate onboarding training for new hires\n\nAdminister change control, deviation, and CAPA processes\n\nCollaborate with cross-functional stakeholders to ensure changes are documented, assessed and approved\n\nSupport qualification and ongoing oversight of critical suppliers, maintain the GxP supplier list and coordinate supplier audits and questionnaires\n\nPrepare quality metrics for management review\n\nAssist with product complaint handling\n\nGenerate and update product specifications, SOPs, templates, forms\n\nQualifications and Experience:\n\nMinimum bachelor's degree in a relevant scientific discipline\n\n5+ years experience in a clinical‑phase biotech environment\n\nHands‑on experience with document control, training management, change/deviation management\n\nStrong written and verbal communication skills with the ability to author clear, concise quality documents\n\nHighly organized, detail‑oriented, and able to manage multiple priorities simultaneously in a small‑team environment\n\nCompensation & Benefits\n\nBase salary range: $120,000 – $140,000 per year, based on the candidate’s professional experience level. Final salary may consider factors such as skills, education, and experience.\n\nAnnual performance‑based bonus, annual equity awards and a comprehensive benefits package.\n\nAt 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.\n\nAll employment is decided on the basis of qualifications, merit, and business need.\n\n#J-18808-Ljbffr","company":"Evolving Solution Services","rawCompany":"evolving solution services","city":"Berkeley","state":"CA","isRemote":false,"isActive":true,"createdAt":"2026-07-02T03:27:46.008Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Specialist, Quality Systems","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\n\nSenior Specialist, Quality Systems\nFull Time, Berkeley, CA, US\n\nRay 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 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.\n\nWe 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.\n\nEssential Duties and Responsibilities:\n\nAdminister the electronic Quality Management System including document control, training records, and workflow management\n\nManage the GxP training program including curriculum development, assigning, and tracking\n\nCoordinate onboarding training for new hires\n\nAdminister change control, deviation, and CAPA processes\n\nCollaborate with cross-functional stakeholders to ensure changes are documented, assessed and approved\n\nSupport qualification and ongoing oversight of critical suppliers, maintain the GxP supplier list and coordinate supplier audits and questionnaires\n\nPrepare quality metrics for management review\n\nAssist with product complaint handling\n\nGenerate and update product specifications, SOPs, templates, forms\n\nQualifications and Experience:\n\nMinimum bachelor's degree in a relevant scientific discipline\n\n5+ years experience in a clinical‑phase biotech environment\n\nHands‑on experience with document control, training management, change/deviation management\n\nStrong written and verbal communication skills with the ability to author clear, concise quality documents\n\nHighly organized, detail‑oriented, and able to manage multiple priorities simultaneously in a small‑team environment\n\nCompensation & Benefits\n\nBase salary range: $120,000 – $140,000 per year, based on the candidate’s professional experience level. Final salary may consider factors such as skills, education, and experience.\n\nAnnual performance‑based bonus, annual equity awards and a comprehensive benefits package.\n\nAt 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.\n\nAll employment is decided on the basis of qualifications, merit, and business need.\n\n#J-18808-Ljbffr","datePosted":"2026-07-02T03:27:46.008Z","dateModified":"2026-07-02T03:27:46.008Z","hiringOrganization":{"@type":"Organization","name":"Evolving Solution Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Berkeley","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e1ecd44729c6c7d413332bdc"},"url":"https://jobsearcher.com/jobs/e1ecd44729c6c7d413332bdc"}}