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Senior Specialist, Global Systems and Compliance

Company: Takeda
Location: Somerville
Posted on: January 10, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Sr. Specialist, Global Systems and ComplianceLocation: Cambridge, MAAbout the role:The Senior Specialist, Global Systems and Compliance reports to the Associate Director, Global Systems and Compliance to help coordinate the quality systems, including documentation, training, deviation/OOS/CAPA, product complaint, change control and LIMS (Laboratory Information Management System) processes supporting Takeda Vaccines (VBU). We ask that you work with numerous functions within the department , global Takeda, vendors and partners.You work with functional management and other quality colleagues to ensure that all GxP systems are in a state of compliance and inspection readiness.Manage electronic Learning and Documentation Management System (DMS/LMS), including administration, and training and document compliance for all GxP users.With oversight from Quality Systems management and VBU Quality leadership, provides guidance and coordination necessary to direct quality system support activities for the department .Coordinate and communicate regional and global processes that support Takeda Quality Management System (QMS)You help implement QMS, to include global and local procedures, and associated training content and delivery ensuring target employees have adequate training assignmentsHow you will contribute:GeneralSupport department reviews, including quality councils and implementation of Global Standards and ProcessesSupport Departmental strategy in the implementation of Continuous Improvement Projects within the DepartmentQuality Management System (QMS)You manage the daily operations of VBU quality systems.Help with the development and administration of the training to support regulated activitiesYou implement developed strategies to ensure best practices are incorporated into the development of documented procedures and specified required training (globally and regionally)You provide advice and expertise to employees to ensure the development, management, and implementation of controlled documented procedures and business essential policy and procedures with associated training are performed based on departmental guidance.Support administration of VBU GxP document lifecycle states in the DMS and training assessments and assignments to applicable personnel in LMSHelp coordinate quality events/processes (deviation, change control and other systems) and support review board activities as applicableYou support quality metric reporting and periodic assessment of the health of VBU quality systemsSupport process and technology projects for VBU and Takeda quality systems; participate in continuous improvement projectsSupport the life cycle maintenance of procedures supporting quality systems in compliance with regulations and Takeda policiesCreate reports, monitor training compliance and perform tracking and trending of relevant training data. Evaluate gaps and develop corrective actions to close gaps.Ensure new personnel have appropriate GxP training assignments and provide new hire training for applicable quality systemsComplianceSupport compliance functions such as inspection readiness/remediation activities, generation of Key Indicators for performance and compliance monitoring, and continuous improvementsWhat you bring to Takeda:Typically requires an academic degree in Science or Engineering (advanced degree preferred) and 5 years of experience in the pharmaceutical IndustryExperience with Investigational and Commercial troubleshootingExperience in different Quality functionsExperience managing global communitiesWhat Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportProfessional training and development opportunitiesTuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants.#GMSGQ#ZR1EEO 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 time

Keywords: Takeda, Somerville , Senior Specialist, Global Systems and Compliance, Other , Somerville, Massachusetts

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