<p>Reporting to the Senior Director, Quality, the Associate Director, Quality - GMP will be responsible for GMP quality oversight for Kiniksa's clinical-stage programs, including activities at Kiniksa's internal Manufacturing Laboratory and at contract service providers. Scope includes manufacture of cell banks, drug substance, drug product, combination products and finished product. The Associate Director collaborates with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other stakeholders, to support and implement phase-appropriate solutions that protect patient safety, enable programs to advance through clinical development to commercialization, and enhance operational effectiveness.</p> <p>Strong preference for Medical Device experience. Please highlight this experience in your resume/cover letter.</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. Relocation assistance is not offered for this position.</p> <p>Responsibilities (including, but not limited to):</p> <ul> <li>Represent Quality Assurance on cross-functional teams, e.g., product development, device development, technology transfer, regulatory dossier preparation, inspection readiness </li><li>Support the Senior Director in the development of a small team of QA professionals </li><li>Develop, implement, and improve procedures related to all aspects of device development and GMP manufacturing of clinical materials </li><li>Assist business owners with supplier selection and management </li><li>As required perform supplier qualification and compliance monitoring audits </li><li>Assist in the implementation of quality systems to support combination products, e.g., deviation, investigation, CAPA, change control, engineering changes and product complaint </li><li>Identify and monitor quality system indicators, and assuring GMP operations at Kiniksa and contractors are performed in compliance with CGMP </li><li>Prepare for and facilitate regulatory inspections and other external audits </li><li>Perform person-in-Plant functions at CMOs </li><li>Approve master documents e.g. batch records, specifications etc </li><li>Evaluate and contribute to proposed changes in conjunction with change control review board </li><li>Disposition GMP Raw Materials and Intermediate Products, make recommendations to the Kiniksa Responsible Person for technical release of finished products to clinic. </li><li>Review and approve complex manufacturing and test records, discrepancy reports, investigations and CAPAs </li><li>Coordinate and conduct product complaint investigations </li><li>Identify and promptly escalate critical risks, and collaborate on quality risk management </li><li>Proactively identify improvement opportunities and drive change </li><li>Provide QA support to QC, including lab inspections and method qualification and transfer </li></ul> <p>Qualifications:</p> <ul> <li>8+ years of relevant experience in a regulated pharmaceutical or medical device environment and 3 years in Quality Assurance. </li><li>Bachelor's degree in science, engineering, biochemistry or related fields, or its equivalent is required. </li><li>Extensive knowledge of US and EU Medical Device and CGMP regulations and guidance </li><li>Strong technical expertise in QA/QC, Manufacturing, and Supply Chain processes </li><li>Demonstrated strong written and verbal communication skills </li><li>Proven mindset of proactive continuous improvement </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>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><li>Kiniksa Benefits Summary - USA </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> <p>It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.</p>