Job Description
The Senior Director, Quality will be responsible for leading Quality strategy and execution across clinical development, spanning candidate selection through to registration and product launch.
Serve as both the strategic and operational leader to direct, oversee and manage all clinical quality assurance activities.
Provide leadership, direction and mentorship across all levels of the organization to assure quality assurance strategies are understood and implemented.
Collaborate with various functions to determine appropriate quality improvement and compliance priorities and plans.
Lead the development and subsequent maintenance of a phase-appropriate, company-wide electronic Quality Management System (eQMS) that meets internal company standards and external regulatory and customer requirements.
Partner with IT to ensure that digital strategies employ appropriate data integrity principles.
Ensure compliance to regulatory guidance through all stages of clinical and product development.
Ensure processes are developed, maintained, and reviewed than ensure Bicycle sponsored clinical trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
Partner with regulatory affairs to assess new and emerging regulations and apply in a fit for purpose manner to Bicycle’s QMS and practices and anticipate any changes that may impact the development strategies for programs.
Collaborate with Regulatory Affairs to ensure regulatory submissions compliant to GxP and global regulations.
Coordinate the preparation, and management of regulatory agency inspections, including vendor inspections and Pre-Approval inspections.