Associate Director, Clinical Quality Assurance

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.

Reporting to the Executive Director of R&D Quality Assurance, the Associate Director, Clinical Quality Assurance (CQA) is responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and pharmacovigilance activities. The incumbent is also responsible for supporting relevant processes and programs ensuring appropriate computer system validation/assurance (CSV/A) activities are completed for applicable clinical systems. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance across clinical development programs and relevant departments including clinical development, trial operations, pharmacovigilance, clinical data sciences, and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.

ESSENTIAL JOB FUNCTIONS:

• Develop collaborative partnerships with clinical study teams/study team leaders to maintain a current understanding of potential areas of quality risk exposure within the context of ongoing clinical studies and across clinical programs as assigned.
• Ensure compliance with clinical quality assurance activities including facilitating and managing internal and external GCP audits/audit programs, as applicable.
• Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance
• Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
• Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues.
• Provide related training on new regulatory requirements and industry practices.
• Lead and manage clinical inspection readiness activities for assigned programs and other key programs as applicable.
• Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable.
• Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs.
• Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs.

JOB SPECIFICATIONS:

• BA/BS degree required, advanced degree a plus
• A minimum of 8 years of experience in the bio-pharmaceutical R&D industry with at least 6 or more years in a current, hands-on GCP Quality Assurance
• Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
• Demonstrated knowledge and application of Global regulations and guidance for GCP, GVP, and CSV/A
• Direct experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs.
• Experience preparing for, participating in, and sub