Kailera Therapeutics, Inc.
Manager,GxPQualitySystems
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optimal for Mid candidates.
“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
Full Job Description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.) Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence Evaluate opportunities for continuous improvements across the systems Work with stakeholders to ensure appropriate documentation of Service Provider se
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