• Administrator for the test management systems • Identify and implement improvements to QA processes • Become a domain expert on the systems under test • Drive and optimize test case prioritization and automation road mapping • Optimize existing automation scripts and performance management • Increased focus on automated scripting • Create risk based test plans/strategies and automation designs • Create complex SQL statements • Review and provide feedback to the PM/BA teams on missing requirements dependencies and high risk issues • Provides trainings and assists in the onboarding process • Design and execute manual and automated test cases for functional regression and/or performance testing including both back-end and front-end systems

• own end-to-end testing of key Raya features and experiments • collaborate with our entire engineering organization to come up with testing strategies and plans • monitor app performance to ensure smooth delivery of new features and updates • support the QA and Client Engineering team initiatives for Raya and Places, by Raya • leverage AI tools to enhance test coverage, generate test cases, analyze logs, or improve QA workflows

Quality Specialists plays a critical role in ensuring that products, services, and processes meet internal and external standards and requirements. The Senior Quality Specialist supports quality initiatives by managing audits and suppliers, analyzing quality data, managing client complaints, internal deviations, and CAPAs, overseeing the document and change management processes, participating in root cause analysis, and collaborating cross-functionally to drive continuous improvement across the organization. Maintain and enforce company quality systems in accordance with applicable standards (e.g., ISO 9001, GxP) Ensure compliance with internal procedures, customer requirements, and regulatory guidelines. Compile quality system data for presentation in Management Review Participate in internal and external audits and support audit readiness efforts. Coordinate and provide oversight to the supplier management process. Promote a culture of continuous improvement, accountability, and operational excellence. Own the document control process and assist in the creation, review, revision, and approval of standard operating procedures. Support change management processes, ensuring proper documentation and validation activities. Manage the end-to-end process for addressing complaints, deviations, and CAPAs. Lead or support the investigation and documentation of complaints and deviations including root cause analysis and identification of CAPA. Ensure all complaint and deviation records are accurate, complete, and compliant with applicable regulatory and quality standards. Monitor complaint and deviation trends and provide regular reports to management with recommendations for improvement. Track and verify the effectiveness of implemented CAPAs. Develop and/or deliver training materials on quality-related policies, procedures, and processes. Serve as a resource for teams on quality standards and best practices. Coordinate with the Learning and Development team to ensure development and assignment of quality-related training. Analyze quality metrics, prepare trend reports, and suggest opportunities to optimize processes and reduce quality risks. Collaborate with cross-functional teams to implement process improvements and quality initiatives.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The (Sr.) Director, GCP & GLP QA will ensure robust quality assurance systems and procedures are in place to cover REGENXBIO’s pre-clinical activities through clinical trial operations. You will also ensure non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements as well as regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. You will have the opportunity to interface and collaborate with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions. - Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies - Authors and/or reviews and approves Standard Operating Procedures (SOPs) - Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required - Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines - Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed - Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget - Participates in or leads internal and vendor audits to ensure patient safety and data integrity - Oversees clinical quality event and CAPA process - Develops and delivers training on good clinical practice concepts and specific GCP procedures - Represents QA at internal clinical and GCLP team meetings - Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations - Effectively communicates progress and issue resolution to appropriate internal/external stakeholders - Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company’s policies and procedures - Facilitates/lead QA activities for GLP/GCP regulatory inspection management - Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization - Plans, resources, and manages staff to ensure efficient operations and encourage development of capabilities - Must be able to travel up to 10-20% of time Qualifications - BS, preferably in a biological science - Must have direct job experience in a Clinical QA or GLP QA role - Extensive experience conducting and overseeing audits - Extensive knowledge of FDA and EU regulations as well as ICH guidelines - Minimum of 10 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment - Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company - Ability to interpret regulations and practically apply them to procedures - Excellent oral and written communication skills for effectively interfacing with internal and external organizations - Strong project management skills - Ability to manage multiple priorities with aggressive timelines and changing priorities - Must have excellent attention to detail - Possesses strong critical and logical thinking - Basic proficiency in MS PowerPoint, Excel and Word Benefits - Market-competitive base salary - Annual performance-based bonus program - Stock grants at all levels - Health, dental, and vision insurance - Retirement plan with 401(k) match - Summer hours - Estimated compensation range for this role is $190,000 to $330,000 annually