Senior Manager of Quality Systems - Remote

Overview

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.

In Short

• Collaborate with GxP departments and external vendors.
• Ensure QMS processes and tools are compliant and user-friendly.
• Manage external and internal audit schedules.
• Support development of metrics related to Vendor Quality.
• Assist in reviewing and updating Quality Agreements.
• Manage electronic document and quality management systems.
• Support continuous improvement projects for GxP systems.
• Track and support closure of Quality Events.
• Ensure inspection readiness for QMS elements.
• Participate in audits and regulatory inspections.

Requirements

• Minimum of 5 years in FDA regulated industry.
• Experience with Veeva Quality Docs, Training, and QMS.
• Strong customer focus and ability to prioritize.
• Self-motivated and detail-oriented.
• Understanding of industry regulations.
• Clear writing and communication skills.
• Proficiency in Microsoft Office and SharePoint.
• Bachelor’s degree required.

Benefits

• Comprehensive health benefits.
• Flexible time off and paid holidays.
• Monthly wellness stipend.
• Generous 401(k) match.
• Disability and life insurance.