Senior Manager, Supply Chain Quality Lead

Role Summary

Senior Manager, Supply Chain Quality Lead responsible for oversight and support of distribution quality activities in the USA, developing quality awareness, mentoring processes for effective quality management systems, and ensuring seamless processes for patient access to medicines. Provides QA oversight of worldwide product distribution logistics, deviations, CAPAs, Change Controls, audits, and serialization.

Responsibilities

• Ensure quality and uninterrupted supply through application of quality measures across the supply chain and ensure quality systems remain compliant with regulations
• Approve shipping qualification for passive and active cooling in transportation; support ex-US internal logistics shipping qualification
• Ensure regulatory inspection readiness for distribution
• Provide oversight of distribution procedures in the USA including oversight of distribution partners
• Establish and maintain Quality Agreements to ensure 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 process of Global Commercial Quality
• QA management of processes related to suspect or illegitimate medicines, returns and recalls
• Quality support of pipeline growth and continuous supply of product
• Participate in new product launch planning and identify quality actions for launch readiness
• Other duties as assigned

Qualifications

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

Skills

• Quality Assurance and distribution management
• Cold chain and temperature-controlled logistics
• Regulatory readiness and audit support
• Quality Agreements and KPI monitoring
• Project management and cross-functional collaboration
• Vendor management and issue resolution

Education

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

Additional Requirements

• Travel requirements not specified
• Physical demands not specified