Senior Associate R&D Quality and Risk Management

<div class="content-intro"><p></p> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow"><strong data-ogsc="" data-olk-copy-source="MessageBody">About Acadia Pharmaceuticals</strong></span></div> <div data-ogsc="black">&nbsp;</div> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow">Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.</span></div></div><p><strong><u></u></strong></p> <h3>Please note that this position can be based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.</h3> <p><strong><u></u></strong></p> <p><strong><u>Position Summary:</u></strong></p> <p>This role will work closely with the other team members in Quality Risk &amp; Compliance (QRC) to assist in assessment, reporting on compliance and improvement of processes, tools and systems for Acadia clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Good Pharmacovigilance Practices (GvP), and Good Laboratory Practices (GLP). Involvement in process improvement projects with Subject Matter Experts (SMEs) of multiple functions in clinical research and other departments, is often part of daily activities. This position requires great timekeeping skills, interpersonal collaboration and a great level of independence to carry out assigned tasks.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Independently calculate, track, QC, and report assigned Key Quality Indicator (KQI) metrics as surrogates for process compliance (semi-automated metrics and manual Spot-Checks) in order to reinforce adherence to processes and procedures and to identify areas for improvement. Liaise between QRM team and clinical study team members on responses to escalations and when thresholds are reached.</li> <li>Create and design, where appropriate, KQI metrics / Spot-Check instructions to harmonize the calculation and reporting to R&amp;D functional areas and other dep