[Remote] Senior Manager, Clinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. Kura Oncology is a commercial-stage biopharmaceutical company focused on discovering and developing innovative precision medicines for cancer treatment. The Senior Manager, Clinical Quality Assurance (CQA) will oversee quality and compliance processes for clinical development programs, ensuring adherence to GCP and fostering a quality-focused culture within the organization.ResponsibilitiesDevelop collaborative partnerships with clinical study teams to provide GCP compliance guidance and advice across assigned clinical programsEnsure compliance with clinical quality assurance activities including facilitating and supporting internal and external GCP audits/audit programs, as applicableSupport 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 assuranceAssist 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 issuesSupport clinical inspection readiness activities for assigned programs and other key programs as applicableSupport 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 applicableSkillsBA/BS degree required, advanced degree a plusA minimum of 6-8 years of experience in the bio-pharmaceutical R&D industry with at least 3 or more years in a current, hands-on in a manager-level GCP Quality AssuranceDemonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs)Demonstrated knowledge and application of Global regulations and guidance for GCP (knowledge of GCLP and or GVP a plus)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 programsExperience preparing for, participating in, and subsequent response to health authority GCP/GVP inspections/partner auditsWorking knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plusExcellent oral and written communicationAbility to manage multiple projects and demanding timelinesOperational Experience (e.g., Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantageExercises independent judgement in managing operational decisions within their area; proactively identifies issues and determines when to escalate more complex or cross functional decisionsServes as a key point of contact for cross-functional partners within their area; ensuring alignment and proactively addressing coordination needs to support team deliverablesBenefitsGenerous benefitsEquityParticipation in an annual target bonusCareer advancement/ development opportunitiesCompetitive comp packageBonus401K + Employer contributionsGenerous stock optionsESPP Plan20 days of PTO to start18 Holidays (Including Summer & Winter Break)Generous Benefits Package with a variety of plans available with a substantial employer matchPaid Paternity/Maternity LeaveIn-Office Catered lunchesHome Office SetupLifestyle Spending StipendCommuter Stipend (Boston Office)Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!Company OverviewKura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives. It was founded in 2014, and is headquartered in La Jolla, California, USA, with a workforce of 201-500 employees. Its website is http://www.kuraoncology.com/.