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Senior Director, Clinical Compliance and Risk Management
Posted on 7/12/2022
INACTIVE
Locations
West Vancouver, BC, Canada
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Management
Requirements
  • A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred
  • At least 8 years of experience in a Good Clinical Practice (GCP) regulated discipline is required
  • Knowledge of the global drug development process is required
  • Experience in a GCP quality role is required
  • Experience in and/or knowledge of risk management in a regulated industry is required
  • In depth technical clinical operations experience/knowledge at site level is preferred
  • Ability to operate in a matrix organization is preferred
  • The candidate will demonstrate the ability to adopt a biopharma enterprise-wide mindset, to act with speed, accountability and integrity, and to have fun along the way
Responsibilities
  • Collaborate with key stakeholders to develop and implement a process for management of quality issues
  • Engage stakeholders to utilize processes and technologies in support of Quality Management Systems (QMS) processes
  • Embed a sustainable GDO Quality Culture & execute the GDO related QMS
  • Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate
  • Identify trends to enhance training and process improvements, assurance that findings from the Accompanied Monitoring Program are tracked and acted upon as part of a wider QMS
  • Oversee vendor activities in relation to monitoring activities in accordance with the Accompanied Monitoring Program
  • Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities
  • Identify and support the development & implementation of technical training across GDO and within the respective region
  • Assure inspection readiness within the respective region through implementation of the GDO audit management plan, on-site support during site Health Authority inspections and/or local sponsor Health Authority inspections in partnership with BMS global quality organization
  • Coordinate local health authority site inspections or sponsor inspections as necessary
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.