Senior Manager, Supply Chain Quality Lead

Role Summary

Senior Manager, Supply Chain Quality Lead responsible for oversight and support to distribution quality activities within the USA, developing quality awareness across processes, and ensuring effective quality management systems. Liaises with Pharma Operations & Technology division and external partners to assure seamless processes and patient access to medicines. Holds QA oversight of global distribution logistics, deviations, CAPAs, Change Controls, audits, and serialization.

Responsibilities

• Ensure quality and uninterrupted supply through quality measures across the supply chain and compliant quality systems
• Approve shipping qualification for passive and active cooling in transportation; support ex-US internal logistics shipping qualification
• Ensure regulatory inspection readiness for distribution
• Oversee distribution-related procedures in the USA, including oversight of distribution partners
• Establish and maintain Quality Agreements to assure product quality and uninterrupted supply
• Conduct regular Quality Management Reviews with distribution partners and monitor KPIs
• Manage projects related to product distribution and improvement of standards and compliance
• Support governance of Global Commercial Quality
• QA management of processes related to suspect or illegitimate medicines, returns, and recalls
• Provide quality support for pipeline growth and continuous supply of product
• Participate in new product launch planning and identify required quality actions for product launches
• Other duties as assigned

Qualifications

• Required: Bachelor‚Äôs Degree in life sciences, supply chain, or related field
• Required: Minimum of 10 years of GMP and/or GDP experience for medicinal/pharmaceutical products within a Quality Assurance logistics environment
• Required: Quality and distribution expertise, including cold chain and deep frozen products
• Required: Outstanding communication skills, including delegation, influencing, stakeholder management, and networking
• Required: Ability to work independently to drive projects to completion
• Required: Vendor management experience
• Required: Demonstrated experience resolving distribution issues impacting medicinal products
• Preferred: Experience supporting global teams across multiple time zones

Skills

• Quality Assurance and distribution management for pharmaceutical products
• Cold chain and temperature-controlled distribution
• Regulatory inspection readiness and quality systems compliance
• Project management and cross-functional collaboration
• Vendor and stakeholder management

Education

• Bachelor‚Äôs Degree (required); preferred in life sciences, supply chain, or related field

Additional Requirements

• None beyond listed responsibilities and qualifications