Associate Director, Quality Assurance (Commercial Supply Chain)

Role Summary

Associate Director, Quality Assurance (Commercial Supply Chain) responsible for driving end-to-end supply chain compliance with FDA and DEA regulations while improving operational efficiency. You will 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, delivering higher stakeholder satisfaction.

Responsibilities

• 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 and 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.

Qualifications

• 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 at sites, business, network, company.
• Ability to influence and work effectively globally.
• Risk identification, evaluation and management.
• Continuous improvement.

Skills

• Digital proficiency and analytical skills
• Six Sigma or Lean Management
• Strong communication, negotiation and stakeholder engagement skills
• Ability to collaborate and partner effectively at all levels, globally, regionally and cross-functionally
• Ability to lead through change and influence

Education

• Scientific degree (BSc, MSc).