Manager/Senior Auditor, Clinical QA
If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following page: REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities. The opportunity : As the Manager of Clinical QA you will have the opportunity to work cross-functionally with our Medical Organization in support of our quality systems covering our clinical trial operations. You will responsible for managing internal and external audit activities for clinical studies in our gene therapy program, provide QA support for CAPA investigations and risk assessment and remediation of Clinical Quality Events and develop and improve our Clinical QA programs and procedures to promote compliance to domestic and international regulatory and industry standards. What you'll be doing: Develop and improve our clinical 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 Author and/or review and approved Standard Operating Procedures (SOPs) and Work Instructions (WI). Perform document review and/or audits of clinical documents. These may include protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms Develop clinical audit plans and conducts and/or facilitates the selection of contract auditors to support the clinical audit program, as required Evaluate internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines, including but not limited to: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical), and Trial Master Files Participate in/or leads internal or vendor audits to ensure patient safety and data integrity Provide QA support for risk assessment and remediation, and identification and investigation/CAPA of Clinical Quality Events. Represent Clinical QA on internal clinical study team meetings. Develop and delivers training on good clinical practice concepts and specific GCP procedures/topics Support key quality processes, metrics and indicators to measure trend and improve key quality determinants of all aspects of GCP and supporting GxP operations Effectively communicate progress and issue resolution to appropriate internal/external stakeholders Support regulatory inspections as the clinical quality representative Promote a culture of quality, innovation and operational excellence You must be able to travel domestically and internationally - approximately 15-25% What we're looking for: We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications: BS in scientific discipline Minimum of 7 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment Must have direct job experience in a Clinical QA role Practical knowledge of US and internal GCP regulations, and ICH E6 Guideline for Good Clinical Practice Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company Excellent oral and written communication skills for effectively interfacing with internal and external organizations Strong initiative and project management skills Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities Auditing experience (investigator, internal and vendor) preferred, Auditing certifications a plus Why should you apply? By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need. We offer a comprehensive and competitive benefit & compensation package which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more! In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and have access to development resources to help you grow personally and professionally.