Senior Manager/Associate Director, Clinical Quality Assurance

ESSENTIAL JOB FUNCTIONS:

Reporting to the Executive Director of R&D Quality Assurance, the Sr Manager/Associate Director, PV-GCP (Pharmacovigilance-Good Clinical Practice) is primarily responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for pre and post-marketing Pharmacovigilance activities and will provide QA GCP support to assigned clinical development programs.. The incumbent may also be responsible for supporting relevant processes and programs that ensure computer system assurance (CSA) for applicable clinical/PV systems. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance for PV and other relevant departments including clinical development, trial operations, clinical data sciences, and other stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.

• Develop collaborative partnerships with PV and assigned 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 pre and most marketing PV requirements, and GCP activities including facilitating and managing internal and external PV/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 PV inspection readiness activities 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
• For Senior Manager a minimum of 6 years, Associate Director a minimum of 8 years of experience in the bio-pharmaceutical R&D industry with at least 4 years (6 for AD) or more years in a PV/GCP Quality Assurance Pre and post marketing PV experience is required.
• Minimum 2 years of experience leading teams, projects, programs or direct reports required.
• Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
• Demonstrated knowledge and application of Global regulations and guidance for GVP, and GCP, and an understanding of requirements for validated computerized systems used in clinical trials and PV
• 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 GVP/GCP inspections/partner audits.
• Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus.
• 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.
• Operational Experience (e.g., PV Operations, 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 this role is $170,000 - $206,000 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.

 

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