Director, RBQM Operations

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We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.Clinical Quality Management (CQM) at TakedaClinical Quality Management is responsible for implementing an enterprise-wide strategy for Risk Based Quality Management (RBQM) and Adaptive Monitoring (AM) to focus on critical-to-quality risks that drive data quality and site performance across the entire study lifecycle.OBJECTIVES:This position reports to the head of Clinical Quality Management (CQM) and leads a team of Risk Based Quality Management (RBQM) Coordinators to support study teams with implementing RBQM methodology at study level, including initial and recurring risk identification, assessment, and mitigation activities within the RBQM frameworkACCOUNTABILITIES:Lead a team of RBQM risk coordinators to support study teams with the implementation of RBQM strategies including study-level risk identification, assessment, and mitigation activitiesEngage RBQM Enablement team for complex findings requiring interpretation from Central Statistical Monitoring (CSM)Consult Adaptive Monitoring Excellence team for signals requiring action and/or adjustment to study-level plans for targeted Source Data Verification and Source Data ReviewDetailed responsibilities of the RBQM Operations group include:Liaise with study teams on the development of Study Risk Assessment (SRA)Interpret study protocol to define key data for analysis in CSM solutionFacilitate study-level risk review meetings with cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecycleTriage risks to study team for action, ensuring effective flow of RBQM outputs and communication to key stakeholdersMonitor timely resolution of risk signals and/or issues identified using CSM solutionsWork with QA and compliance functions to ensure corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functionsCreate signal and trending reports for study teams and support their interpretation of RBQM outputPerform data review using analytics/visualizations (CSM) to review aggregate data to help study teams identify issues and emerging risksIn collaboration with Clinical Operations, ensure appropriate oversight and mitigation of CtQ risks, including preparation for inspection readinessSupport sponsor inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM frameworkMay represent CQM in governance meetings to promote the adoption of RBQMServe as a Subject Matter Expert (SME) and process owner for RBQM activities, procedures, and technologiesIdentify and ensure dissemination of RBQM best practices across studies, programs, and functionsStay abreast of best-in-industry practices and levers current knowledge to improve Takeda’s RBQM oversight and complianceEDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:Education: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experienceExperience: Minimum of 10 years of experience in the pharmaceutical or CRO industryMinimum of 5 years of experience in Risk Based Quality ManagementMinimum of 5 years of managerial and supervisory experienceExperience with all phases of development in one or more therapeutic areas preferredAdvanced knowledge of broad drug development process and expertise in the cross-functional interfaces for the adoption of Risk Based Quality ManagementKnowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, and WHODRUGSkills:Robust understanding of the drug development process and clinical trial executionKnowledge of RBQM IT systemsExperience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive ActionsDemonstrated excellence in cross-functional project/program managementAptitude for data analytics and understanding of statistical conceptsStrong track record of building solid partnerships and cross-functional collaborationsSupports a culture of continual improvement and innovation; promotes knowledge sharingAbility to influence without authorityEntrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quoTravel: 10-20%Base Salary Range: $200-220K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSummaryLocation: Boston, MAType: Full time