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Senior Specialist, Global Systems and Compliance

Company: Takeda Pharmaceutical Company Ltd
Location: Boston
Posted on: January 16, 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 Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Job Title: Sr. Specialist, Global Systems and Compliance Location: Cambridge, MA About 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 assignments How you will contribute: General * Support department reviews, including quality councils and implementation of Global Standards and Processes * Support Departmental strategy in the implementation of Continuous Improvement Projects within the Department Quality Management System (QMS) * You manage the daily operations of VBU quality systems. * Help with the development and administration of the training to support regulated activities * You 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 LMS * Help coordinate quality events/processes (deviation, change control and other systems) and support review board activities as applicable * You support quality metric reporting and periodic assessment of the health of VBU quality systems * Support process and technology projects for VBU and Takeda quality systems; participate in continuous improvement projects * Support the life cycle maintenance of procedures supporting quality systems in compliance with regulations and Takeda policies * Create 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 systems Compliance * Support compliance functions such as inspection readiness/remediation activities, generation of Key Indicators for performance and compliance monitoring, and continuous improvements What you bring to Takeda: * Typically requires an academic degree in Science or Engineering (advanced degree preferred) and 5 years of experience in the pharmaceutical Industry * Experience with Investigational and Commercial troubleshooting * Experience in different Quality functions * Experience managing global communities What Takeda can offer you: * Comprehensive Healthcare: Medical, Dental, and Vision * Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan * Health & Wellness programs including onsite flu shots and health screenings * Generous time off for vacation and the option to purchase additional vacation days * Community Outreach Programs and company match of charitable contributions * Family Planning Support * Professional training and development opportunities * Tuition reimbursement More 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 #ZR1 EEO Statement Takeda 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical Company Ltd, Boston , Senior Specialist, Global Systems and Compliance, Other , Boston, Massachusetts

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