<p>Reporting to the Director, Clinical Quality Assurance, the Associate Director, Clinical Quality Assurance will assist in leading Kiniksa's Bioresearch Monitoring (BIMO) Inspection Readiness program to ensure all good practice regulations (GxP), including Current Good Manufacturing Practices (CGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP), have been met.</p> <p>This role will be responsible to initiate, execute, and report on clinical trial quality issues in accordance with the International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)/GCP and all other applicable requirements (including local regulations) to support the licensure of pharmaceutical products, both domestically within the United States as well as in global international markets.</p> <p>Furthermore, this role will lead the implementation and enhancement of Kiniksa's current GCP Quality Management System (QMS); identify all gaps; and implement a three-phase QMS implementation project plan. Their specialty occupation duties will include the following</p> <p>This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.</p> <p>Responsibilities (including, but not limited to):</p> <ul> <li>Develop and implement quality assurance drug regulatory compliance programs </li><li>Conduct investigator site, service provider, and internal audits as needed to ensure adherence to drug manufacturing regulations </li><li>Develop, review, and revise SOPs for GCP/Good Laboratory Practices (GLP)/Good Pharmacovigilance Practices (GVP) quality assurance processes </li><li>Promote regulatory compliance within the company by representing QA </li><li>Assist in providing oversight of commercial PVG systems and ensure compliance to GVP requirements </li><li>Lead the regulatory compliance program to ensure companywide awareness of latest changes to regulatory requirements </li><li>Build, develop, and maintain good working relationships with internal and external partners to ensure cross functional staff members are informed regarding regulatory and quality requirements </li><li>Matrix manage projects, including cross-functional teams, for regulatory inspection readiness and to maintain regulatory compliance </li><li>Provide compliance advice as requested or needed to guide our clinical operations employees on regulatory issues </li><li>Lead regulatory inspections, in agreement with QA management, to maintain compliance </li><li>Participate in company preparations for regulatory inspections: represent the quality function to ensure Kiniksa meets regulations pertaining to ICH E6 </li><li>Review and identify improvements that enhance the quality assurance system </li><li>Assist Quality Management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement </li><li>Establish and maintain quality metrics and reporting to ensure the health of our drug quality and the regulatory compliance of clinical trials </li><li>Coordinate, develop, maintain and/or provide training as requested on regulatory compliance activities </li><li>Keep up with GCP/GLP/GPV requirements and developments to ensure Kiniksa remains current with regulatory requirements </li></ul> <p>Qualifications:</p> <ul> <li>7+ years of experience in the pharmaceutical/biotech industry/CRO and 1+ years of CQA leadership experience. </li><li>Bachelors or Advanced degree in a scientific discipline required. </li><li>Successful track record in managing CROs as well as leading all internal CQA duties. </li><li>Understanding of worldwide requirements of GCP/GMP/GVP, regulations and standards, and quality systems for commercial and clinical products. </li><li>Experience interacting with Regulatory Health Authorities at pre- and post-approval inspection. </li><li>Established expertise and training in GxP systems. </li><li>Demonstrated strong written and verbal communication skills </li><li>Efficient independent worker with ability to focus and drive for results </li><li>Strong attention to detail </li><li>Ability to work in a fast paced-environment and to handle multiple tasks </li><li>Proven mindset of proactive continuous improvement </li><li>Strong commitment to compliance and ethical standards </li><li>Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) </li><li>Ability to travel up to [5%] </li><li>Salary is commensurate with experience </li></ul> <p>Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>