Senior Specialist, Distribution Quality Assurance

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

Protecting our tomorrow

Job Title: Senior Specialist Distribution Quality Assurance

• Location: Remote (East Coast Preferred)
• Department: Global Quality
• Reports To: Senior Director, Quality
• Salary Range: $145k - $195k

About Bavarian Nordic

Bavarian Nordic is a global vaccine company focused on helping to protect lives through innovative vaccines, public health partnership, and expanded access to disease prevention.

We work across emerging infectious diseases, travel health, and public health preparedness to help communities, healthcare providers, pharmacies, and health systems improve vaccine awareness, access, and delivery.

With a growing commercial portfolio and strong global partnerships, Bavarian Nordic is evolving how vaccines are supported across healthcare ecosystems, combining scientific innovation with customer engagement, education, and public health impact.

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

Qualifications

• 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%.

Why Join Us

Join a mission-driven global vaccine company at a pivotal stage of growth and evolution. At Bavarian Nordic, you’ll have the opportunity to help shape innovative commercial programs, support public health initiatives, and contribute to how vaccines are accessed across healthcare channels.

We foster a collaborative, entrepreneurial culture where cross-functional partnership, creativity, and impact are valued alongside scientific excellence.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com