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Job Description

Title: Associate Director, Quality Assurance (Commercial Supply Chain)

Location: Lexington, MA

About the role:

As an Associate Director, Quality Assurance (Commercial Supply Chain), you will drive end‑to‑end supply chain compliance with FDA and DEA regulations while improving operational efficiency. You will also drive strategic initiatives that enhance product quality and optimize supply chain efficiency. You will be a Strategic Quality Business Partner working with Global Supply Chain and USBU to streamline and continuously improve quality processes, resulting in higher stakeholder satisfaction.

How will you contribute:

• Provide leadership and Quality subject matter expertise across the Takeda US network, prioritizing timely resolution of product quality issues.

• Maintain the Quality Management System in support of supply chain models, focusing on activities such as coordinating internal/external quality agreements (excluding agreement signature) and ensuring compliance oversight.

• Responsible for ensuring timely resolution of product quality & compliance issues occurring in the US supply chain, in compliance with Takeda QMS and local regulatory requirements.

• Partner with US Domestic Distribution Logistics, US Global Logistics and USBU to streamline and continuously improve processes in a compliant manner.

• Provide Quality leadership, creates and implements strategies to assure the appropriate monitoring, oversight and governance across Global Takeda Managed access initiatives (ATM, PAP, US Donation partners).

• Primary contact to support US manufacturing sites and OpUs for Regulatory Inspection inquiries regarding US distribution and GDP topics.

• Bring knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance, and other relevant supply chain activities, with a heavy emphasis on US regulations as administered by the FDA and DEA.

• Familiarity with different supply chain & distribution models, and associated quality oversight design requirements.

• Excellent  communication  and  negotiation  skills,  crucial  during  regulatory  audits  and  stakeholder meetings.

• Six Sigma or Lean Management, enhancing the ability to streamline processes and improve quality outcomes.

• Ability to provide a sound interpretation of applicable regulations.

• Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally.

• Ability to lead effectively through directing change, as well as driving change by influence. Accountable for decisions on GxP/pharmaceutical activities to ensure regulatory compliance of Takeda supply chain activities.

• Responsible for developing and leading global supply chain quality initiatives in alignment with strategic quality priorities and business / stakeholder needs.

• Key interactions with global and regional stakeholders including Global Supply Chain, OpUs, BUs/Commercial/USBU, Legal, Tax, procurement

• Key interactions with numerous stakeholders in Quality including OpU Quality, External Supply Quality, LOCs.

• Understanding of industry and business, applicable legislation and regulatory compliance requirements.

• Digital proficiency and analytical skills, applied in developing data-driven strategies that improved supply chain efficiency.

• Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products.

What you bring to Takeda:

• Scientific degree (BSc, MSc).

• Demonstrated increasing management responsibility, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution.

• In-depth knowledge of global pharmaceutical operations, supply chain and distribution management, and Quality. 

• Strong interpersonal skills include excellent communications skills; adept at influencing and negotiating, conflict management, and the ability to lead teams in a complex and changing environment.

• Focusing on the few priorities and providing superior results, thus advancing the GQ Roadmap.

• Digital and analytical skills.

• Strong skills engaging stakeholders: sites, business, network, company.

• Ability to influence and work effectively globally.

• Risk identification, evaluation and management.

• Continuous improvement.

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:

USA - MA - Hayden - 45-55

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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

USA - MA - Hayden - 45-55

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.