Head Global Quality Device Compliance US / ROW region

Head of Global Quality Device Compliance

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. 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.

You will :

• Provide strategic quality compliance direction and oversight for GxP medical devices.
• Serve as main quality compliance person with responsibilities for Device and Combination Products.
• Support oversight of compliant lifecycle management of GxP devices.
• Partner with Device Compliance heads for the EU / CAN region and for the China / Asia region.
• Support and execute applicable QMS processes supporting Device QMR responsibilities.
• Partner with critical stakeholders in Regulatory Affairs, Device Quality, and PharmSci.
• Serve as Device Management Representative for US and Rest of World countries.
• Be responsible for oversight of internal and external audits and inspections.
• Attend Management Review and Quality Council for Device and Combination Products Quality Systems.
• Engage with stakeholders to enhance and execute sustainable Device Quality support.

What You Bring to Takeda :

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 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.

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.