Job Details

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 Manager, Clinical Quality Assurance. As a study team member, you will report to the Vice President, Head of Clinical Operations, Science & Quality, and will be responsible for ensuring internal and external sites are inspection ready, resources are provided on site and/or remotely during health authority inspections, observational findings are responded to appropriately and within the required timeframe, and resultant CAPAs are implemented and checked for effectiveness to prevent recurrence. Assisting in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and appropriate corrective actions are implemented and documented on a timely basis.

Key responsibilities include but not limited to the following:

• Collaborate with Clinical team to develop systems for vendor management and vendor oversight
• Support the development and execution of the GCP and GVP audit strategy and plan using a risk-based approach
• Plan and manage the conduct of GCP and GVP internal audits and external audits (vendors, clinical sites, etc.) to assure that the clinical department is meeting regulatory requirements and follows Global and Local procedures
• Interface with relevant departments, including regulatory, clinical sub teams, clinical manufacturing and others, as applicable, to provide GCP and GVP compliance expertise
• Assist in GCP and GVP Regulatory health authority inspection activities and the development of corrective actions for findings from such inspections
• Establish and maintain a system to ensure GCP and GVP metrics are available for Senior Management Reviews per Company requirements
• Manage GCP and GVP quality issues from investigation through root cause analysis and CAPA closure by partnering with internal/external stakeholders
• Develop and implement Clinical Quality Risk Management Plans for clinical trials and safety
• Identify continuous improvement opportunities, new technologies, and innovations and implement processes and systems that increase efficiency and compliance
• Managing compliance and risk mitigation to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible

Qualifications:

• Bachelor's degree required
• Minimum 5 years of experience in a regulated pharmaceutical environment
• Strong understanding of GCP and PV Quality.
• Experience with audits and global regulatory inspection support required.
• Experience in implementing global regulations in clinical trials, pharmacovigilance and product surveillance.
• Experience implementing and ensuring GCP and GVP quality (e.g., GCP oversight, auditing, electronic systems management, global inspection readiness.)
• Demonstrated ability to work efficiently across multiple project teams and business functions
• Excellent verbal, written and organization skills
• Proficient with Microsoft Office applications, Adobe and document management templates
• Up to 20% travel is required, based upon business needs

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.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $95,000 to $120,000, 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.

All employment is decided on the basis of qualifications, merit, and business need

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