Overview
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:
Reporting to the Executive Director of Quality Assurance, the Senior Manager, 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. 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.
- Develop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programs.
- Ensure compliance with clinical quality assurance activities including facilitating and supporting internal and external GCP audits/audit programs, as applicable.
- 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.
- Support 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.
Job Specifications:
- BA/BS degree required, advanced degree a pllus
- A minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level 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 (knowledge of GCLP and or GVP a plus).
- 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 subsequent response to health authority GCP/GVP inspections/partner audits.
- Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus.
- Excellent oral and written communication
- Ability to manage multiple projects and demanding timelines.
- Operational Experience (e.g., Clinical Operations, Data Management, ), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage.
- Exercises independent judgement in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross functional decisions.
- Serves as a key point of contact for cross-functional partners within their area; ensuring alignment and proactively addressing coordination needs to support tea deliverables.
