Associate Director, Clinical Quality Assurance

Summary

Join Kura Oncology, a leading biotech company focused on precision medicine for cancer treatment, as an Associate Director/Director, Clinical Quality Assurance (CQA). Reporting to the Senior Director of Quality Assurance, you will play a crucial role in developing and implementing quality and compliance processes for clinical development programs and pharmacovigilance activities. You will collaborate with clinical study teams, ensure compliance with GCP, GVP, and CSV/A regulations, and lead inspection readiness activities. This role requires a minimum of 8 (Associate Director) or 10 (Director) years of experience in biopharmaceutical R&D, including significant experience in GCP Quality Assurance. Kura Oncology offers a competitive compensation package, including generous benefits, equity, and a bonus.

Requirements

• BA/BS degree required, advanced degree a plus
• For Associate Director a minimum of 8 years, for Director, minimum of 10 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
• Minimum 2 years of managerial experience directly leading projects, programs or directing the allocation of resources required
• 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 subsequent response to health authority GCP/GVP inspections/partner audits
• Working knowledge of Veeva (or similar QMS e-system) required
• Ability to write clear quality position statements, risk-based audit reports, and procedures
• Excellent oral and written communication
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines

Responsibilities

• 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

Preferred Qualifications

• 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
• Knowledge of Inspection Management Tools a plus

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!