Senior Specialist, Distribution QA
Bavarian Nordic
Summary
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.
Job description
Position Overview
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.
Key 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
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
- Ability to travel up to 20%
Benefits
- Salary Range: $145k - $195k
- Remote (East Coast Preferred)
Company overview
Bavarian Nordic is a global vaccine company headquartered in Copenhagen, Denmark, with over 30 years of experience in developing life-saving vaccines. Founded in 1994, the company has evolved from a small biotech startup into a fully integrated vaccine company focused on the research, development, manufacturing, and commercialization of innovative vaccines. Bavarian Nordic employs over 1,400 dedicated professionals across multiple international locations including Denmark, Germany, the United States, Canada, Switzerland, Italy, Spain, and the United Kingdom. The company is recognized as a global leader in smallpox and mpox vaccines, developed through its long-standing partnership with the U.S. Government to enhance public health preparedness. Their portfolio also includes vaccines for travelers and endemic diseases, with a strong focus on infectious diseases and biodefense. Bavarian Nordic operates as a pure-play vaccine company with a firm commitment to improving and saving lives through innovative immunization solutions, maintaining a diverse workforce bound together by their mission to protect lives every day.