Global Head of Quality Assurance

Global Head of Quality Assurance (VP/SVP)Company ProfileRakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India.Position SummaryThe Head of Quality Assurance (QA) will be a key member of the Rakuten Medical team with Global responsibility for establishing and administering all Quality functions related to our drug, device and clinical operations. The Head of QA will provide quality oversight and support Rakuten Medical’s product manufacturing, product distribution, pre-clinical, clinical oversight, and operations.The chosen candidate will lead global quality and report to the President of Rakuten Medical. The candidate will have strong leadership, communication, collaboration skills with the ability to prioritize, set goals and meet objectives applying a risk-based compliant approach while working with cross-functional teams.Key Duties and ResponsibilitiesResponsible for the establishment and administer Rakuten Medical’s Quality Management System (QMS)Responsible for all quality functions related to clinical, commercial, product manufacture which includes the combination of drug and deviceEnsure the company compliance with relevant global quality and regulatory requirementsContributes to the development of clinical trial protocolsResponsible for the Rakuten Medical electronic document management systems (EDMS)Interprets relevant guidelines/processes information and takes appropriate actions to inform and educate stakeholders and revise processes as necessaryOversee the global vendor selection, assessment, and qualificationOversee the quality audits, inspections and budget of the Rakuten Medical vendorsProvide device quality oversight of design and development activities, ensuring compliance with design control requirements (21 CFR 820.30, ISO 13485)Participate in device design reviews, risk management activities (ISO 14971), and verification/validation processesMonitor and maintain compliance with ICH-GCP, FDA, EMA, PMDA, and other applicable regulatory guidelinesSupport implementation of risk-based quality management for clinical trials per current ICH guidelinesOversees the investigation of quality-related issues, development and implementation of corrective and preventative action plans (CAPA), tracking their effectiveness and presenting metrics to leadershipResponsible for generating a preapproval compliance strategy for Rakuten Medical commercial productsSupport and provide guidance on late stage process validation activitiesEnsure annual licenses, registrations, listings, and patent information are maintainedEnsure compliance with product post-marketing approval requirementsSupport advertising and promotional items are compliant to regulatory requirementsReview and approve publicly disseminated informationReview product claims and preserves confidentiality of applicable product informationOversee quality aspects of business relationships to ensure compliance and protect corporate interestsRepresents the organization during regulatory agency inspectionsRecruit, develop, and manage the Quality Assurance functional areas as the company’s pipeline and development activities growDesired Education, Skills and ExperienceExtensive biopharma experience in clinical research and quality assurance, with a strong understanding of GCP, cGMP, GLP, GVP, GDP, device QMS, and other relevant regulations and standardsExperience with both drug and device supporting oncology trialsFunctional head of a quality departmentExperience of Management Representative per ISO 13485 preferred10+ years of Quality Assurance industry experienceExperience monitoring costs of projects, as well as human and material resources within a department or unitExperience in preparing, hosting and managing regulatory inspections (includes FDA, EMA, MHRA, PMDA) for both manufacturing and clinicalStrong critical thinking, problem-solving, and decision-making skills, as well as dealing with ambiguityStrong organizational and time-management skills to manage multiple projects and priorities effectivelyExcellent oral and written communication skillsBusiness travel is typically up to 15-20% of time, but it may be higher on occasion based on business needsAbility to work independently, analyze, work with attention to detail, and process and prioritize sensitive complex informationExcellent interpersonal, team building, and motivational skillsRakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills. #J-18808-Ljbffr