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 across processes and mentoring for effective quality management systems. Liaises with Pharma Operations & Technology and external functions to ensure seamless processes and patient access to medicines. Provides QA oversight of global product distribution logistics, including deviations, CAPAs, Change Controls, audits, and serialization.

Responsibilities

• Ensure quality and uninterrupted supply through quality measures across the supply chain and maintain 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 procedures in the USA and management of distribution partners
• Establish and maintain Quality Agreements to assure product quality and uninterrupted supply
• Hold regular Quality Management Reviews with distribution partners and monitor KPIs
• Manage projects related to product distribution and improvements in 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
• Participate in new product launch planning and identify quality actions required for launch
• Other duties as assigned

Qualifications

• Required: Bachelor's Degree (life sciences, supply chain, or related)
• Minimum of 7 years of GMP and/or GDP experience in a Quality Assurance logistics environment for medicinal/pharmaceutical products
• Quality and distribution expertise, including cold chain and deep-frozen products
• Outstanding communication, delegation, influencing, stakeholder management, and networking abilities
• Ability to work independently to drive projects to completion
• Vendor management experience
• Demonstrated experience resolving distribution issues impacting medicinal products
• Preferred: Experience supporting global teams across multiple time zones

Skills

• Quality management systems and regulatory compliance
• Distribution and logistics quality control
• Quality agreements and governance
• CAPA, deviations, Change Controls, and audits
• Cold chain and temperature-controlled logistics
• Cross-functional collaboration and program management

Education

• Bachelor's Degree required; preferred in life sciences, supply chain, or related fields

Additional Requirements

• Hybrid work arrangement: 3 days on site; location options include Cambridge, MA or Research Triangle Park, NC