Remote Manager/Sr. Manager, Clinical GCP Quality Assurance

Note: The job is a remote job and is open to candidates in USA. Rakuten Medical, Inc. is a global biotechnology company focused on developing precision therapies using its Alluminox technology platform. The Manager/Senior Manager of Clinical GCP Quality will lead the evaluation and mitigation of risks in global clinical development programs, ensuring compliance with regulations and overseeing quality management systems throughout clinical trials.ResponsibilitiesProvide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activitiesSuccessfully lead global and cross-functional quality projectsMaintains current knowledge of ever-changing clinical quality guidance and regulationsExcellent communication and people skills to ensure cohesive and collaborative teamworkDemonstrated ability to implement and collaboratively drive company initiatives and policiesExperience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferredDirect experience to successfully manage and oversee CAPA plans (write, review, approve, close)Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actionsEstablish Quality and Cross-Functional SOPs, processes and associated documentsWorking closely with clinical pharmacovigilance team on supporting clinical trial safetyResponsible for presenting & updating CGP quality metrics and reporting to Sr. ManagementOther duties as assignedSkillsAt least 10 years of experience in clinical quality, process improvement, regulatory inspection managementAt least two years of clinical auditing experience as lead auditorExcellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan)Provide strategic and operational leadership in the planning and executing of GCP Quality activitiesSuccessfully lead global and cross-functional quality projectsMaintains current knowledge of ever-changing clinical quality guidance and regulationsExcellent communication and people skills to ensure cohesive and collaborative teamworkDemonstrated ability to implement and collaboratively drive company initiatives and policiesDirect experience to successfully manage and oversee CAPA plans (write, review, approve, close)Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actionsEstablish Quality and Cross-Functional SOPs, processes and associated documentsResponsible for presenting & updating CGP quality metrics and reporting to Sr. ManagementB.S. Degree in life sciencesAdvanced degree in a scientific disciplineMinimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experiencePrevious experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experiencePharmacovigilance/Safety QA experienceMedical Device GCP experienceISO Standard (e.g. ISO13485, ISO9001, ISO27001) understandingMedical Device Reporting (MDR) FDA 21 CFR Part 803Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoringExperiences with Clinical Quality Management on a risk-based approachElectronic TMF, document, quality, and learning management systems experienceStrong organizational and project management skillsFlexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environmentProfessional working proficiency in EnglishBenefitsFlexible time offStock options401kMedicalDentalVision plansCompany OverviewRakuten Medical is a biotechnology company developing investigational cancer therapies based on its proprietary Alluminox platform. It was founded in 2010, and is headquartered in San Diego, California, USA, with a workforce of 51-200 employees. Its website is https://rakuten-med.com. Apply To this Job .