Kailera Therapeutics, Inc.
Manager,GxPQualitySystems
“Manager, GxP Quality Systems at Kailera Therapeutics, Inc.. Skills: Quality Systems, GxP, Veeva, Compliance. Support Quality Management System processes. Track and support closure of Quality Events”
Industry & Context.
resolve day-to-day issues
What They're Looking For.
Must Have
Minimum of 6+ years of experience in FDA regulated industry, Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required, A customer focus and ability to prioritize and adapt to business needs are required business partner with all Functional Areas to ensure efficient collaboration and to drive results, Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities, Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards, Clear, concise writing skills and good verbal communication and presentation skills, Bachelor’s degree in Life Sciences or a related field
What You'll Do.
Support Quality Management System processes
Track and support closure of Quality Events
Support management of GxP training program
Conduct Document Control reviews
Support establishment
and reporting on metrics
Support the management of the electronic document management system
Ensure the systems remain in a validated state
Evaluate opportunities for continuous improvements
Work with stakeholders to ensure appropriate documentation
Support development of metrics related to Service Provider qualifications
Manage and track Audit Schedule
How You'll Work.
Team & Collaboration
cross-functional coordination; Work with stakeholders
Communication Scope
verbal communication; presentation skills; writing skills
Process & Methodology
managing multiple projects
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