Senior Manager, Quality Systems

Quality is experienced (and valued) by patients as a reliable and dependable product or service that is safe and improves their health or well-being. Health Care Professionals (HCPs) and Payers expect and value something similar. Health Authorities demand quality by enforcement of laws and regulations and finally our Business sees quality as a key determinant of our reputation. To deliver quality to all these customers and stakeholders, Kura Oncology adopts a Quality Management System which assures our products and services are delivered using a consistent set of processes and tools.

The Sr. Manager of Quality Systems supports the Quality Management System (QMS) that assures employees perform their work in a consistent high-quality manner.  This involves providing strong technical and organizational leadership to drive the development, maintenance, and use of the QMS. 

The incumbent has a GxP focus and will ensure that QMS processes, procedures, systems, training, and tools are fully utilized by the Kura Oncology organization to help achieve and maintain quality and compliance.

ESSENTIAL JOB FUNCTIONS:

• Supports the management and continuous improvement of the QMS electronic systems including:
  • Document management system (EDMS)
  • GxP Vendor management
  • Learning management (LMS)
  • Inspection management system
  • Audit and Inspection management including quality event and CAPA management
  • Development and reporting of quality metrics
• Supports the development and maintains processes for Computer Software Assurance (CSA) and Change Management.
  • Works in partnership with other GxP Business System Owners.
• Supports management of the External and Internal Audit programs.
  • Maintains sufficient; qualified auditors; schedules audits; manages audit communications, reports and responses to closeout.
• Supports the GxP vendor qualification process and maintains qualified vendor list.
• Supports the GxP training program and role-based training curriculums.
• Provides training, access and support to Employees for Veeva Quality Vault users.
• Provides established metrics, reports on metrics that track/measure and evaluate effectiveness of the Kura QMS.
• Participate in managing regulatory inspections and external audits including for example: training and use of inspection management system, managing back-room activities logistics, and communications.
• Work with Centralized Contracting and Outsourcing to aid in Vendor Selection and Qualification.
• Support a continual state of inspection readiness for the QMS elements.
• Other Quality Assurance responsibilities, as assigned.

JOB SPECIFICATIONS:

• Minimum of 8 years for Sr. Manger of experience in a quality role within biopharmaceutical development or manufacturing setting. At least 3 years managing quality systems is required.
• Demonstrated experience supporting and managing Quality Management System required. Experience in a multi-vault eQMS is required. Experience in the Veeva Vault Platform is strongly preferred.
• A strong customer focus and ability to prioritize and adapt to business needs are required.
• Self-motivated, independent, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
• Strong understanding and knowledge of applicable industry regulations.
• Proactive approach to problem solving.
• Clear, concise writing skills and good verbal communication and presentation skills.
• Proficiency in using the internet, Microsoft Word, Power Point, Excel, Adobe, and SharePoint.

The base range for a Senior Manager is $118,000 - $143,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.