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Job Description

Job Title: Senior Manager, PSDQ Compliance (Hybrid)

Location: Lexington, MA

About the role:

As the Senior Manager of PSDQ (Pharmaceutical Science and Device Quality) Compliance you will have oversight for the overall In-Vitro Diagnostic (IVD)

device 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 Quality.

How you will contribute:

• Responsible for the compliance of Takeda Global Quality Device and Combination Products (DCP) processes and quality records through regulatory intelligence analysis of changing device and IVD (In-Vitro Diagnostic) regulations.

• Leadership activities for technical and quality systems audits and inspections including internal, customer, notified body or health authority.

• Subject matter expert for global IVD device regulations for clinical to commercial programs.

• Device audit and inspection roles to including host on specific topics, Back-room lead, front room liaison, scribe and QC reviewer. Manage associated Trackwise Record to ensure audit is documented, audit findings are investigated with appropriate CAPAs identified and completed.

• Responsible for continuous improvement of IVD and associated processes by working cross-functionally to identify and implement actions.

• Pressure test device Vigilance Assessments in Trackwise to ensure compliance with global health authority reporting requirements.

• Presenting QMS trends or information on IVD and combination product topics to senior PSDQ management.

• Identify trends and/or improvement opportunities based on analysis of metric data from the wider device organization including Technical and Regulatory activities.

• Identify Regulatory Intelligence that is/is not applicable to Takeda. Gap assess regulatory intelligence impacting more than one Takeda process. Liaise cross-functionally on regulatory intelligence impacting more than just Device Quality.

• Manage data quality processes that impact multiple device teams.

• Be a liaison for regulatory compliance for a given site.

• Collaborate with global teams; project/program management and operational excellence

What you bring to Takeda:

• Bachelor's Degree in Science, Engineering or equivalent technical discipline required

• 6 years of experience working with IVD and combination products in a regulated healthcare industry, with 4 years Quality Assurance and/or Quality Compliance roles

• Experience with EU, US and international IVD and combination products regulations and standards including but not limited to 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

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

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work in a cold and/or wet environment.

• Must be able to work multiple shifts, including weekends.

• Non-Exempt Roles only: Must be able to work overtime as required.

• 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 #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.

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