<p>About Aura:</p> <p>Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.</p> <p>For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.</p> <p>Position Summary:</p> <p>Aura Biosciences is actively recruiting for an Associate Director (AD) of GCP Quality Operations in support of clinical trial execution of Aura's drug development programs. The AD of GCP Operations provides assurance of patient safety and data integrity and support in the execution of the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement. This is a vital position in the success of Aura's GCP function, including proactive study support, supporting internal Quality initiatives/procedures, auditing, and inspection readiness. The successful candidate will have a strong foundation in GCP Quality in the planning, conduct, reporting and close out of GCP audits (e.g. Investigator Site, Clinical Process, TMF, Database, Clinical Suppliers) and proactive GCP support of ongoing trials in all phases with both internally sourced and CRO outsourced trials. Experience in internal Quality Event Management and CAPA, sponsor Regulatory Health Inspections and inspection readiness planning is highly desired.</p> <p>Responsibilities include but are not limited to:</p> <ul> <li>Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation). </li><li>Conduct external audits (includes, but is not limited to investigator sites, central IRBs, CROs and clinical labs). </li><li>Track and review audit responses and ensure acceptability of CAPAs. </li><li>Provide guidance and support to Clinical Operations staff and other GCP-related departments, as applicable, based on interpretation of current regulations to ensure the best practice including risk-based management. </li><li>Assist in the development of Inspection Readiness program and assist senior staff during regulatory inspections. </li><li>Work closely with Clinical Operations on assigned studies to provide proactive GCP compliance support. </li><li>Support clinical Quality Event and CAPAs with review of investigation, root cause and implementation planning and timeliness. </li><li>Assist with departmental metrics trending and reporting. </li><li>Support the development of GCP documents and provide quality review and guidance where needed. </li><li>Review protocols, monitoring plans, ICFs, other study related forms as required. </li></ul> <p>Minimum Requirements:</p> <ul> <li>BS in life science field or related field required. Equivalent professional experience will be considered. </li><li>10+ years of direct GCP pharmaceutical/biotechnology experience and auditing </li><li>Solid understanding and application of FDA regulations, ICH/GCP, GLP, MHRA, EMA, Health Canada. </li><li>Excellent written and oral communications skills </li><li>A well organized, self-motivated and independent work style. Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to ensure effective interactions within and across departments. </li><li>Works seamlessly with other cross-functional departments </li><li>Ability and willingness to travel domestically and internationally for audits. </li><li>GLP/GVP experience is a plus </li></ul> <p>Salary & Benefit Information:</p> <p>Salary Range: $160,000/yr - $215,000/yr</p> <p>(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)</p> <p>Health insurance with FULL premium coverage</p> <p>401K with company match</p> <p>Employee Stock Purchase Program (ESPP)</p> <p>Competitive paid time off (PTO)</p> <p>Company-paid short & long-term disability insurance and life insurance</p>