R&D Quality Assurance Senior Associate II

3 hours ago

Princeton, United States Aequor Technologies Full time
Title: Sr. Quality Risk & Compliance Associate
Location: Princeton, NJ
Duration: 12 Months

Job Description:
  • 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 clinical trials' execution in a Good Clinical Practices (GCP) regulated environment.
  • Additional areas of support focus on Research & Development, R&D functional areas, including Drug Safety and Pharmacovigilance (GvP), pre-clinical research, Good Laboratory Practices (GLP), and involvement in cross-functional process improvement projects with Subject Matter Experts (SMEs) of a multiple functions in clinical research and other departments.
  • 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.
  • 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, support a clinical study, provide independent feedback to 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 R&D (Research & Development) 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 R&D Quality Management team.
  • Onboarding of other (new) members of the QRC team where applicable.

Required Skills:
  • Experience with R&D specific IT application systems for Document management, trial management, Data 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.
  • 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.
  • 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.

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