Director/Sr. Director, Clinical Quality Assurance - Boston, MA, United States - Kura Oncology, Inc.

Description

ESSENTIAL JOB FUNCTIONS:

Reporting to the Head of Quality Assurance, the Director/Sr. Director, Clinical Quality Assurance (CQA) is responsible for 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 the process and program that ensures appropriate computer system validation/assurance (CSV/A) activities are completed for applicable clinical systems. The incumbent builds collaborative, supportive relationships and serves as the single point of accountability for Quality Assurance across all clinical development departments including clinical development, trial operations, pharmacovigilance, data sciences, and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.

• Develop collaborative partnerships with clinical leadership to maintain a current understanding of potential areas of quality risk exposure across the dynamic development environment, as well as new emerging technology and vendor use.
• Ensure the clinical quality assurance activities are comprehensively Develop, direct, and manage the clinical internal, and external audit programs.
• Implements QA activities that support 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
• Develop and lead program for reviews, assessments, and resolution of evolving issues, including process/program reviews to identify improved approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
• Represent clinical quality expertise across the Communicate changing regulatory requirements, evaluate new/updated regulations and guidance. Work cross-functionally to identify potential gaps in current process. Provide related training.
• Manage the clinical inspection readiness program, and the overall clinical quality assurance strategy. Collaborate with multiple cross-functional departments (e.g., Vendor Management) to ensure clinical vendors have appropriate quality-related selection, approval, agreements, and on-going
• 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 to make certain that strategies are utilized consistently across programs.
• Partner with the key stakeholders (e.g., clinical, clinical operations, pharmacovigilance, and other relevant stakeholders) to develop quality metrics (e.g. KQI, KPI leading and lagging) using tools including, but not limited to: quality reviews and assessments, artificial intelligence, data analytics, and audits to provide data and information to inform leadership and teams on the state of quality for individual studies and clinical programs.

JOB SPECIFICATIONS:

• BA/BS degree required, advanced degree a plus.
• Minimum of 10 years of experience in the bio-pharmaceutical R&D Director-level requires a minimum of 4 years, Sr. Director requires a minimum of 6 years of current, hands-on GCP Quality Assurance experience.
• Minimum 2 years of managerial experience directly leading people and/or leadership experience leading teams, projects, programs or directing the allocation of resources required.
• Substantial experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)
• Demonstrated knowledge and application of ICH regulations and guidance for GCP, GVP, and CSV/A activities.
• 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.
• Ability to write clear quality position statements, risk-based audit reports, and
• Excellent oral and written communication
• Strong judgment, project management and decision-making skills; able 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.

The base range for a Director is $213,450 - $225,174 and Senior Director is $262,500 - $280,000 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.