Job Description

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.

Principal Responsibilities:

·       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
Quality organization.



·       12 years’ + experience in Quality Systems within
the pharmaceutical industry.

·       Prior experience in a global QA role at the
management level

·       Demonstrated critical thinking and
problem-solving skills.

·       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)