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Kura Oncology, Inc. · 1 day ago

Senior Manager/Associate Director, Clinical Quality Assurance

Boston, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$170K/yr - $206K/yr

6+ years exp

Kura Oncology is a clinical-stage biopharmaceutical company committed to making a meaningful impact on cancer treatment through precision medicines. The Senior Manager/Associate Director, Clinical Quality Assurance will support the development and implementation of quality and compliance oversight processes for Pharmacovigilance activities and provide QA support to clinical development programs.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine

Comp. & Benefits

Responsibilities

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

Qualification

PharmacovigilanceClinical PracticeQuality AssuranceGlobal regulations knowledgeInternalExternal auditsVeeva QMS experienceProject managementCommunication skillsTeam leadership

Required

BA/BS degree required, advanced degree a plus

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

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