Senior Associate R&D Quality and Risk Management

Acadia Pharmaceuticals Inc.•Princeton, NJ

20h•$32 - $40•Hybrid

About The Position

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.

Requirements

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.
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).
Highly proficient in Information Technology systems, including Microsoft Office suite and related generative A.I. systems.
Proven experience in time management, and good email practice in order to work on multiple assignments at the same time.
Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between.
Strong analytic skills for large quantities of compliance, risk management and clinical data and calculation of related KQIs and Spot Checks depending on those data sets.
Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development.
Interest in, and/or experience with organizational change management, as it relates to embracing and promoting a culture of quality.

Nice To Haves

Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference.
Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects.
Pursuing or in possession of a (Lean) Six Sigma certification (yellow, green, black, or master black belt) is a big plus.
Ability to travel in exceptional cases.

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.

Benefits

Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance