Senior Associate R&D Quality and Risk Management

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About Acadia Pharmaceuticals 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. 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. Position Summary: This role will work closely with the other team members in Quality Risk & 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. Primary Responsibilities: 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. Create and design, where appropriate, KQI metrics / Spot-Check instructions to harmonize the calculation and reporting to R&D functional areas and other departments. Suggest automation and improvements to KQI calculations, where applicable. Contribute to the automation efforts with the owner of the KQI or the system component. Assist QRM team members with the creation and maintenance of a regulatory framework for Quality Risk Management (QRM) related activities, including review or creation of Controlled Documents (e.g. SOPs, Work Instructions) and/or tools, and templates. Assisting in creation of eLearnings, training materials related to GCP, GLP, GvP. Where assigned, provide support to a clinical study team, provide independent feedback in case of study- or clinical site-specific compliance issues, study risks and work with study teams on implementing and documenting solutions and preventive measures, where appropriate. Lead Study-specific staff members through the Veeva Quality Management System (QMS) process for Deviation and CAPA Management, if applicable. Contribute and lead the implementation of Process Improvements in the Acadia R&D (Research & Development) and/or GMP space and contribute to oversight of Process Improvement projects and assist with project management activities as part of the PI3 (Process Improvement and Innovation Ideas) process. Act as SME on Process Improvement initiatives, including brainstorming, risk assessments, implementing changes and action planning, where assigned. Contribute to User Requirement assessments and User Acceptance Testing (UAT) for general technology implementation of new or updated IT applications used for clinical trial management. Also contribute to activities related to Health Authority Inspections, under supervision of senior members of the Quality team. Assist in onboarding of other (new) members of the QRC team where applicable. Education and Experience Bachelor's degree in life sciences, neuroscience, psychology, biochemistry, engineering, Quality (and/or Risk) Management, Clinical Pharmacology or related field. Targeting 2+ years of Pharmaceutical/Health Care experience in a R&D regulated environment including some experience in Risk-Based Quality Management or R&D Quality Assurance systems and Health Authority regulations (e.g. ICH E6; FDA 21 CFR). An equivalent combination of relevant education and applicable job experience may be considered. Key Skills: Experience with R&D specific IT application systems for document, data and trial management, and/or Pharmacovigilance. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar).

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