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.

Requirements

BA/BS degree required, advanced degree a plus
A minimum of 8 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
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. 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., Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage.

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!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCP Quality Assurancestandard operating procedures (SOPs)root cause analysiscorrective action plansrisk assessmentdata integrityclinical inspection readinessquality management principlesprocess improvementmetrics tracking

Soft Skills

communicationproject managementdecision-makingjudgmentcollaborationtrainingorganizational skillsproblem-solvingleadershipadaptability