Senior QA Specialist, External Manufacturing — Remote

Bavarian Nordic; United States; Remote; USD 120,000 - 155,000; Full time

Job summary

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing quality, ensuring aseptic GMP compliance and product integrity for vaccines supplied to patients globally.

The role emphasizes collaboration with CMOs, QPs, and internal stakeholders to drive continuous improvement and maintain high quality standards across vial filling, labeling, and packaging processes. Travel to US sites may be required.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related discipline.
• 10+ years of Quality Assurance experience in pharmaceutical or biotech manufacturing.
• 5+ years of aseptic processing and sterile manufacturing environments is required.
• Demonstrated experience overseeing CMOs/CDMOs is a must.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to travel periodically to manufacturing sites within the US or internationally as needed.

Responsibilities

• Ensuring CMOs maintain the highest levels of Quality standards conforming to cGMP and in conjunction with BN QAA.
• Support the Bavarian Nordic QPs to enable the release of the highest quality vaccines.
• Managing and resolving complex quality-related issues relating to aseptic operations including vial filling and labelling and secondary packing operations.
• Promoting a strong quality culture and driving continuous improvement initiatives across areas.
• Representing QA External Manufacturing in global and cross-organizational forums within Bavarian Nordic.

Skills

Quality Assurance

GMP knowledge

Stakeholder management

Cross-functional collaboration

Auditing

Education

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related discipline

Tools

CMO/CDMO oversight

Aseptic processing knowledge

Job description

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing quality, ensuring aseptic GMP compliance and product integrity for vaccines supplied to patients globally.

The role emphasizes collaboration with CMOs, QPs, and internal stakeholders to drive continuous improvement and maintain high quality standards across vial filling, labeling, and packaging processes. Travel to US sites may be required.