Head Global Quality Device Compliance US/ROW region

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Job Description

About the Role

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, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, effective, and maintained in compliance with all applicable regulatory requirements. This role partners closely with regional Device Compliance leads and cross-functional stakeholders to drive alignment and uphold Takeda’s global device quality standards. You will play a key role in enabling innovation while protecting patient safety across the product lifecycle.

How You Contribute

• 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.
  

What You Bring to Takeda

• Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).

• 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.
  

  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.

  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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.