This role will interface globally with users across Global
Operations, Commercial, Research & Development, IT and Quality to support
execution and monitoring of the global Quality Management System (QMS)
governing Deviation, CAPA and Change Control.
· Use deep process knowledge and experience to
assist global business partners with the creation, review, approval, closure
and monitoring of deviations, investigations, CAPAs, change controls.
· Collaborate with global stakeholders to
identify, plan and lead implementation of value-added improvements to the QMS.
· Proactively identify and communicate risks,
issues, and best practices within the QMS.
· Establish new and improve existing forums for
performance monitoring and end user support.
· Create and update QMS procedural documentations
and work instructions with accuracy and clarity.
· Create and deliver QMS training (process and
· Participate in inspection readiness activities,
self-inspections of the QMS and external audits.
· Other duties as required to support the growing
· 12 years’ + experience in Quality Systems within
the pharmaceutical industry.
· Prior experience in a global QA role at the
· Demonstrated critical thinking and
· Knowledge of global GCP, GLP, GVP, GMP and GDP
requirements for quality systems, medical devices and combination products.
· Direct experience with development and approval
of deviations, CAPAs and Change Controls.
· Prior experience in project planning and
leadership within a matrix environment.
· Prior experience training and coaching for skill
· Excellent written and verbal communication
· Able to plan, prioritize and manage workload and
manage shifting priorities to ensure commitments are met.
· Direct experience with TrackWise desired.
· Bachelor’s degree in a technical or life
sciences discipline (ex. Chemistry, Biology, Biotechnology)