Remote New

Senior Manager, Quality Systems

Kura Oncology
401(k), stock options
United States, California, San Diego
12730 High Bluff Drive (Show on map)
Jan 17, 2025
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. 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 $120,000 - $155,000 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. Kura's Values that are used for candidate selection and performance assessments: We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package 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! Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts. Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura's website atwww.kuraoncology.comand follow us onXandLinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.