Takeda · 2 days ago
Head Global Quality Device Compliance US/ROW region
Lexington, MA
Full-time
Onsite
Director/Executive
$174K/yr - $274K/yr
7+ years expTakeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. As Head of Global Quality Device Compliance for the US and Rest of World region, you will provide strategic direction and oversight for GxP medical devices, ensuring compliance with regulatory requirements and driving alignment across global device quality standards.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Provide strategic quality compliance direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest Of World region (excluding EU, CAN, China, and Asia region)
Serve as main quality compliance person with responsibilities for Device and Combination Products to ensure that the Quality System requirements are established, effective and maintained in accordance with all applicable US and ROW region regulatory requirements
Support oversight of compliant lifecycle management of GxP devices from R&D to discontinuation and establish a common framework and principles for Software as a Medical Device that enable safe innovation and protect patient safety
Partner with Device Compliance heads for the EU/CAN region and for the China/Asia region on all global device activities and support execution of global compliance strategies for Takeda Device and Combination Products in alignment with the overall 1-QMS approach
Support and execute applicable QMS processes supporting Device QMR responsibilities, including oversight of Device-related SOPs, quality councils, inspection support, and industry interactions
Partner with critical stakeholders in Regulatory Affairs, Device Quality, and PharmSci to ensure aligned and effective quality compliance strategies
Serve as Device Management Representative for US and Rest of World countries as needed and participate on teams developing global policies and procedures for Device and Combination Products
Be responsible for oversight of internal and external audits and inspections, including interactions with Notified Bodies and regulatory investigators, and assure tracking and completion of corrective actions
Attend Management Review and Quality Council for Device and Combination Products Quality Systems, assessing quality performance to demonstrate levels of control, capability, and compliance
Engage with stakeholders to enhance and execute sustainable Device Quality support for manufacture, packaging, testing, and release, ensuring compliance with GMPs, Takeda Quality Standards, and regulatory requirements
Qualification
Required
Bachelor's degree in a scientific or technical discipline
7–10 years of experience in medical devices and/or combination products within a regulated healthcare environment, including 5–7 years in Quality Assurance or Compliance
Proven leadership experience (minimum 5 years) with the ability to mentor and coach teams
Expert knowledge of US and Rest of World regulatory requirements for Device and Combination Products
Experience with Class I, II, and III sterile and non-sterile medical devices and related regulatory filings
Strong analytical and risk-based decision-making skills, with the ability to address complex compliance challenges
Demonstrated success collaborating across global, cross-functional teams and regulatory authorities
A proactive, innovative mindset focused on continuous improvement and patient safety
Preferred
advanced degree preferred
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase