Requirements

A bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least 3 years of related work experience. 3+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions. Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

Job Description

You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally. Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure. Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.