Senior Manager, PSDQ Compliance (Hybrid)
Posted on: February 12, 2024
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Job Title: Senior Manager, PSDQ Compliance (Hybrid)
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
- 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
- Responsible for continuous improvement of IVD and associated
processes by working cross-functionally to identify and implement
- Pressure test device Vigilance Assessments in Trackwise to
ensure compliance with global health authority reporting
- 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
- Be a liaison for regulatory compliance for a given
- Collaborate with global teams; project/program management and
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
- Experience with clinical development and regulatory filings
What Takeda can offer you:
- Family-friendly company environment ; Support with parental
leave, dad month, bilingual company kindergarten.
- Work at home depending on the position/department.
- Comprehensive training programs.
- In-house job rotation program.
- In-house canteen with discounts or meal vouchers.
- Works council (events, festivals, shopping vouchers,
- Employee Referral Program.
- Employee Recognition Program.
- Takeda Resource Groups.
- Medical checkups.
- Free vaccination program.
- Fitness Center.
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
- Non-Exempt Roles only: Must be able to work overtime as
- 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
Empowering our people to shine:
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, or
any other characteristic protected by law.
Keywords: Takeda, Boston , Senior Manager, PSDQ Compliance (Hybrid), Executive , Lexington, Massachusetts
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