Senior Manager, Quality Systems

Summary

Join Kura Oncology, a leading biotech company focused on precision medicine for cancer treatment, as a Senior Manager of Quality Systems. You will play a vital role in managing and improving the company's Quality Management System (QMS), ensuring compliance and high-quality standards across all operations. This position requires extensive experience in quality systems within biopharmaceutical settings, strong leadership skills, and a deep understanding of GxP regulations. You will be responsible for overseeing various QMS aspects, including electronic systems, vendor management, training programs, and audits. Kura Oncology offers a competitive compensation package, including a generous benefits package, equity, and a target bonus, along with opportunities for career advancement and a positive work environment.

Requirements

• 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
• 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

Responsibilities

• 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

Preferred Qualifications

Experience in the Veeva Vault Platform is strongly preferred

Benefits

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!