Clinical Quality Assurance Director

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart's development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and dsRNA agonists.Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.We are looking for a Clinical Quality Assurance Director to join our South San Francisco team. This position is an onsite position in our South San Francisco office.The Clinical Quality Assurance Director is responsible for the quality assurance and compliance functions by managing, planning scheduling, overseeing and conducting GCP Quality Assurance activities. This position will evaluate, identify, and reduce compliance risk by contributing to the development and maintenance of efficient and effective clinical quality procedures to achieve the highest level of data quality and integrity. A successful candidate must possess and have demonstrated a strong working understanding of ICH-GCP with experience implementing strategies in support of ICH, FDA and other pharmaceutical industry regulatory guidelines through ph1 through registration. A strong technical understanding of biopharmaceuticals and/or vaccines is highly desired. This position is responsible for leading auditing activities (internally and externally) to ensure quality and data integrity are maintained according to monitoring plans, GCPs and ICH guidelines. The position ensures Vaxart is prepared for regulatory inspections and audits by the development of tools and training for cross-functional departments. This position collaborates closely with cross-functional team members, including clinical operations, analytical development, data management, process development, and regulatory teams.Responsibilities:Drive continuous development and ensure maintenance of systems at Vaxart in compliance with GCP guidelines, including drafting and approving Clinical SOPs and other supporting process documentation.Direct experience setting up Quality Management System.Manage day to day Quality responsibilities.Prepare audit plans and audit/risk mitigation plans.Perform audits on clinical investigator sites, vendors, processes, systems, and study documents to assure quality assurance compliance with regards to internal procedures as well as regulatory guidelines.Clearly communicate and report (verbally and in writing) audit outcomes to the organization and escalate quality issues as required.Provide QA expertise to the organization and quality oversight of the clinical trials, drug safety and translational activities.Evaluate contract partners (e.g., CROs) for the quality aspects, set up and review of procedures with external vendors.Ensure QA oversight of clinical trial protocols, ICFs, CSRs and other clinical trial specific documents as requested. Develop and maintain appropriate TMF management process.Perform eTMF audits.Manage and/or deliver yearly GCP training for staff.Provide advice internally and externally on GCP and quality matters.Proactively lead, or coordinate across, the organization in preparation, coordination, hosting, conducting, documentation and follow up for FDA, EMA or other health authority regulatory inspections.Maintain expert knowledge in regulatory requirements including federal, state and international regulations and applicable standards and guidance.Perform other duties as assigned.Required Skills:BS/BA degree in scientific field with 15+ years' experience in biotech, pharma or CRO drug development.Full understanding of GCP, GLP and GMP regulations and regulatory compliance guidelines.Strong leadership and communication skills.Expert knowledge and interpretation of GCP regulations and standards.Direct experience with BARDA or other government offices would be preferred.Direct experience interacting with FDA, EMA, or other health authority for inspections of sponsor, investigator site(s) and CRO.Extensive knowledge of global regulations and standards.Significant experience with GCP Quality Risk and CAPA Management.Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.Results oriented; able to determine approaches to assignments.Strong interpersonal skills while building/keeping/monitoring quality and compliance.Problem-solving skills with ability to analyze situations and/or data while considering future impact and intangible variables.Multitasks and ability to manage multiple global processes.In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $190,000 - $230,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by.NOTICE TO RECRUITERS AND STAFFING AGENCIES: Vaxart, Inc. has an internal recruiting department. Vaxart may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters ('Agency'). Agencies are hereby specifically directed NOT to contact Vaxart employees directly to present candidates. Vaxart's recruiting team or other authorized Vaxart personnel must present ALL candidates to hiring managers.To protect the interests of all parties, Vaxart will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Vaxart, including unsolicited resumes sent to a Vaxart mailing address, fax machine or email address, directly to Vaxart employees, or to Vaxart's resume database will be considered Vaxart property. Vaxart will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Vaxart will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.The Agency must obtain advance written approval from Vaxart's recruiting function to submit resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. Vaxart will not pay a fee to any Agency that does not have such an agreement in place.Agency agreements will only be valid if in writing and signed by an officer of Vaxart or their designee. No other Vaxart employee is authorized to bind Vaxart to any agreement regarding the placement of candidates by Agencies. Vaxart hereby specifically rejects, and denies any liability under, any agreement purporting to be accepted based on negative consent, negotiation with a candidate, performance, or any means other than the signature of a Vaxart officer.