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　　Job Description

　　Job Title: Principal Manager, PSDQ Compliance

　　Location : Lexington, MA

　　About the role:

　　The Principal Manager of PSDQ Compliance is an experienced quality professional who supports the device and combination product quality strategy to ensure compliance of Takeda's Quality System and products to global device and combination product requirements. You will report to the Head of PSDQ Compliance and Software as Medical Device (SaMD) Quality.

　　How you will contribute:

　　You will maintain and improve compliance of Takeda Global Quality Device and Combination Products (DCP) processes and quality records through regulatory intelligence analysis of changing global device and IVD Regulations.

　　You will be the subject matter expert for multiple Device and Combination Product processes including device vigilance, labeling, regulatory, design control, risk management, and/or technical documentation.

　　Support technical and quality systems audits and inspections including internal, customer, notified body or health authority.

　　You will lead device audit & inspections as well as participate as audit host back-room lead, front room liaison, scribe, and/or quality compliance reviewer. Manage associated Trackwise Record to ensure audit is documented, audit findings are investigated with appropriate CAPAs identified and completed.

　　Identify improvement strategies of Device and Combination Product quality system processes based on analysis of changing regulations, goals, and metrics.

　　Develop and present narrative for Quality Management System (QMS) processes for Management Review / Quality Council by analyzing data trends and providing insights.

　　Conduct gap assessments to changing global regulatory affecting more than one Takeda process. Liaise cross-functionally on regulatory impacting more than just Device and Combination Product Quality.

　　Act as the subject matter expert of Device Quality specific processes/SOPs including device vigilance, labeling, regulatory, design control, risk management, and/or technical documentation.

　　What you bring to Takeda:

　　Bachelor's Degree in Science, Engineering or equivalent technical discipline required, and at least 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with 3 years Quality Assurance and/or Quality Compliance roles.

　　Experience with EU, US and international medical device and combination products regulations and standards including Part 4, CFR 820, 803, ISO 13485, MDSAP, ISO 14971, E.U. Medical Device and In-Vitro Diagnostic Regulation

　　Experience with Class I & II & III sterile and non-sterile medical devices

　　Experience with clinical development and regulatory filings

　　Experience working and collaborating with global teams; project management

　　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 in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body

　　Must be able to work multiple shifts, including weekends.

　　May be required to work in a confined area.

　　Some Clean Room and cool/hot storage conditions.

　　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

　　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

　　Lexington, MA

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time