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Takeda · 15 hours ago

Associate Director, Quality Assurance (Commercial Supply Chain)

USA - MA - Hayden - 45-55

Full-time

Onsite

Lead/Staff, Director/Executive

$154K/yr - $241K/yr

Takeda is a leading global biopharmaceutical company, and they are seeking an Associate Director for Quality Assurance in their Commercial Supply Chain. The role involves driving supply chain compliance with FDA and DEA regulations, improving operational efficiency, and serving as a strategic quality partner to enhance product quality and optimize supply chain processes.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical

H1B Sponsor Likely

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 & 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

Qualification

Quality Management SystemFDA regulationsDEA regulationsSupply chain complianceSix SigmaLean ManagementDigital proficiencyAnalytical skillsRisk managementContinuous improvementInterpersonal skillsCommunication skillsNegotiation skillsConflict management

Required

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