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　　Job Description

　　Job Title: Quality Risk Management and Compliance Lead

　　Location: Lexington, MA

　　About the role:

　　You will lead Massachusetts Biologic Operations (Mass Bio Ops) risk management, incident and gap assessment process to applicable regulations, standards and global procedures and serve as the principal SME and site contact for global QRM and RA teams. You will be a core member of the global QRM Community of Practice, representing the site at the global level and responsible for developing a risk plan for the site and for driving QRM activities within that plan. Help achieve the Quality vision based on Science, Systems and People. Build and promote a Quality Culture through collaboration and partnerships, innovation, continuous improvement, and a learning environment that includes knowledge and best practice sharing.

　　This is a hybrid position that reports to the Head of Quality Compliance.

　　How you will contribute:

　　Establish goals for the Quality Risk Management and Regulatory Intelligence team in alignment with the global and site strategy, and act to ensure timely delivery of goals.

　　Ensure compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Mass Bio Ops.

　　Conduct gap analyses and implements Quality Management System procedures in several departments and manage compliance. Interact with global Quality functions and Regulatory Affairs.

　　Own, execute, and maintain the Quality Risk Management program at the Mass Bio Ops site level inclusive of oversight of periodic review of associated risk assessments.

　　Support and partner on Quality Council meetings, including summaries of the data presented, conclusions, meeting minutes, and tracking action of items to closure.

　　Represent Mass Bio Ops site at the Global Quality Risk Management Community of Practice.

　　Participate in gap assessment and track remediation of site or functional procedures with respect to global QRM standard, as well as implement Quality Management System procedure.

　　Plan and facilitate key risk assessments. Over time, develop the capability to coach and train site/functional colleagues to do the same. Monitor the progress of remediation for identified risks, ensuring completion, and escalating as needed to appropriate Quality forum (e.g., site Quality Council).

　　Responsible for the development and management of the site/functional risk register process.

　　Ensure cross-functional involvement in risk planning and risk-based initiatives for the site and partner with cross-functional teams to harmonize site QRM approach.

　　Provide training and support to site personnel on Takeda's QRM procedures, program, and resources, and seek new ways to improve and streamline current business and system processes.

　　Review site-impacting regulatory and customer responses working with Subject Matter Experts to assure timeliness and accuracy.

　　Manage site specific Incident Notifications and the Product Complaint Management process and coordinate escalations for review. Understand and ensure conformance to applicable regulations.

　　Responsible for the submission of annual Product Quality Reviews and quarterly reports.

　　Complete mandatory training within the required timeframe, and all other duties as assigned

　　What you bring to Takeda:

　　Minimum of BS or BA preferably in the Sciences/Engineering

　　Minimum of 7-10 years of experience in Quality or related field in the pharmaceutical industry.

　　Minimum of 3 years of project management required, including leading teams and managing projects.

　　Knowledge of Quality Risk Management (e.g., ICH Q9, FMEA, PHA, Risk Rank and Filtering, Risk)

　　Knowledge of the local and international regulatory regulations for the manufacture of biological products.

　　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

　　Important Considerations

　　At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

　　Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

　　Occasional domestic and international travel may be required.

　　In general, your work will be mostly sedentary work with occasional walking throughout the facility.

　　Frequent wrist and hand motion (e.g., typing, writing).

　　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 #LI-MA1 #LI-Hybrid

　　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

　　USA - MA - Lexington - BIO OPS

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time