Vice President, Quality Assurance

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Job Description 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.
Essential Job Functions    
• Leads the Quality Unit responsible for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (cGMP), Good Pharmacovigilance Practices (GVP), and Computer Software Validation (CSV).  
• Develops, implements, and manages the Quality System to the standards expected by Health Authorities to support clinical development, commercial operations, and the post-approval product lifecycle.  
• Commercial product disposition and end-to-end quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution activities.  
• Governance and quality oversight of the commercial supplier network, including CMOs, contract laboratories, packagers, distributors, 3PLs, and applicable specialty-pharmacy partners.  
• Oversight of the commercial product quality lifecycle, including product complaints, investigations, returns, field alert reports, recalls, market actions, and counterfeit or product-integrity concerns.  
• Provides Quality oversight for internal GCP, GMP, GLP, and GVP activities.  
• Ensures appropriate Quality oversight of CMOs, laboratories, suppliers, packagers, distributors, 3PLs, and alliance partners  
• Leads Inspection Readiness and/or Inspection Preparedness efforts.  
• Acts as lead/Host contact for GxP site inspections.  
• Manages Quality System Reviews and presents to Management.  
• Evaluates GxP activities for continuous improvement opportunities to the Quality System.  
• Ensures risk-based quality management (RBQM) is applied as appropriate to clinical studies.  
• Manages critical GxP product-quality, data-integrity, safety, and compliance events  
• Identifies potential Quality risks to strategic and/or operational plans and proposes options to mitigate risks.  
• Manages GxP Quality personnel, activities, and budget.
Job Specifications    
• Bachelor’s degree in a Life Sciences discipline or equivalent.  
• A minimum of 18 years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function.  
• Clinical development, commercial launch, and marketed-product lifecycle experience with strong experience supporting NDA approvals, MAAs, commercial launches, and post-approval submissions  
• Experience with developing, implementing, and maintaining GxP Quality System which ensures compliance to GxP and regulatory standards.  
• Experience in managing, hosting and/or supporting Health Authority inspections.  
• Demonstrates proven track record of leadership, communication, and motivation skills with internal and external Vendors.  
• A strong team player with the ability to effectively communicate sound quality advice…