Job Details

Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation.

We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer

The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States.

Position Overview:

The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization.

The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.

Essential Duties and Responsibilities:

• Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO's
• Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards
• Ensure the appropriate identification, evaluation, and management of risks associated with quality
• Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
• Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
• Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
• Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
• Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities
• Prior experience establishing a Quality Department and growing a group.
• Strong knowledge and understanding of clinical trial design.
• Quality Management System (QMS) Oversight:Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
• Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies.
• Prior experience developing GCP / GMP auditing plans.
• Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections).
• Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors.
• Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO's).
• Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence

Qualifications and Experience:

• Minimum bachelor's degree in relevant scientific or engineering discipline.
• 8+ years relevant biotech experience.
• Experience in GMP AAV gene therapy manufacturing preferred.
• Knowledge of AAV analytical methods and testing preferred.
• Experience working with CDMO, CRO's, and other external vendors preferred.
• Experience with clinical quality oversight, SOP generation
• Experience with vendor management and audit planning
• Excellent scientific knowledge and acumen.
• Familiarity with regulatory requirements and documentation
• Ability to travel up to 20%

Compensation Range and Benefits:

• 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.

Search Firm Representatives Please Read Carefully

Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.