Senior Associate R&D Quality and Risk Management

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

Bachelors 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).
• 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.
• 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
• 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.
• Ability to travel in exceptional cases.

Scope

Works both as a member of teams as well as independently without direct supervision. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

While performing the duties of this job the employee is regularly required to stand; walk; sit; use hands to finger handle or feel; reach with hands and arms; climb or balance; stoop kneel crouch see talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 50 pounds. Ability to travel independently overnight up to 10% of the time and work after hours if required by travel schedule or business needs.

#LI-HYBRID

#LI-MS1#