Remote Senior Distribution Quality Assurance Specialist

Regulatory Jobs; United States; Remote; USD 145,000 - 195,000; Full time

Job summary

Bavarian Nordic is hiring a Senior Specialist Distribution Quality Assurance to lead North American distribution QA and act as the primary Quality partner to Supply Chain. The role ensures GDP compliance, oversight of 3PLs, cold chain control, and continuous improvement across distribution networks.

The position requires a Master’s in Life Sciences and 5+ years in pharma/biotech quality, with deep regulatory knowledge and strong stakeholder collaboration.

Qualifications

• Master's degree in Life Sciences or equivalent with pharma/biotech experience.
• Minimum 5 years in quality for pharma, biotech, or vaccine distribution.
• Deep knowledge of GDP, 21 CFR, USP, EudraLex, and PIC/S GDP requirements.

Responsibilities

• Lead Distribution Quality activities for North America.
• Act as Quality Business Partner to Supply Chain operations.
• Provide GDP-related quality approval for records and activities.
• Oversee qualification and management of 3PLs, warehouses, and transporters.
• Ensure compliance of QMS processes, deviations, CAPAs, change controls, and risk assessments.
• Manage Quality Agreements with distribution partners.
• Oversee cold chain and temperature-controlled distribution.
• Support audits and inspections.
• Monitor quality metrics and trends.
• Collaborate with stakeholders to ensure compliant distribution.

Skills

Quality leadership

GDP knowledge

Regulatory compliance

Quality systems

Risk management

3PL oversight

Education

Master's degree in Life Sciences

Job description

Bavarian Nordic is hiring a Senior Specialist Distribution Quality Assurance to lead North American distribution QA and act as the primary Quality partner to Supply Chain. The role ensures GDP compliance, oversight of 3PLs, cold chain control, and continuous improvement across distribution networks.

The position requires a Master’s in Life Sciences and 5+ years in pharma/biotech quality, with deep regulatory knowledge and strong stakeholder collaboration.