Senior Specialist, Distribution QA
Bavarian Nordic•Durham, CA
•$145,000 - $195,000•Remote
About The Position
The Senior Specialist Distribution Quality Assurance serves as the Quality lead for North American distribution operations and the primary Quality Business Partner to regional Supply Chain. This role provides Quality oversight of distribution partners, logistics activities and Quality Systems application to ensure compliant, efficient, and reliable product distribution while supporting continuous improvement across the supply chain.
Requirements
- Master's degree in Life Sciences or equivalent experience
- 5+ years of Quality experience in pharmaceutical, biotechnology or vaccine manufacturing / distribution
- Strong knowledge of GDP requirements and pharmaceutical Quality Systems
- In-depth knowledge of North American regulations, including 21 CFR and USP requirements
- In-depth knowledge of EudraLex and PIC/S GDP requirements
- Experience with QMS processes, audits, supplier oversight, and risk management
- Experience supporting warehouse, transportation and 3PL operations
- Strong stakeholder management, communication and problem-solving skills
- High degree of autonomy and self-drive, with a proactive, self-motivated, can-do approach
Nice To Haves
- Ability to travel up to 20%
Responsibilities
- Lead Distribution Quality activities across North America
- Serve as the primary Quality Business Partner for Supply Chain operations
- Provide Quality oversight and approval for GDP-related activities and records
- Oversee qualification and management of 3PLs, warehouses, and transportation providers
- Ensure compliant execution of QMS processes, including deviations, CAPAs, change controls, complaints and risk assessments
- Manage Quality Agreements with distribution partners
- Provide oversight of cold chain and temperature-controlled distribution activities
- Support audits and inspections
- Monitor quality metrics and trends
- Collaborate with internal and external stakeholders to ensure compliant product distribution
- Promote a strong integrated quality and continuous improvement culture
Benefits
- Equal Opportunity Employer
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What This Job Offers
Job Type
Full-time
Career Level
Senior
