Senior QA Leader, External Manufacturing (Remote)

Bavarian Nordic; Durham (NC); Hybrid; USD 120,000 - 155,000; Full time

Job summary

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing in the US, focusing on aseptic fill-finish operations, regulatory alignment, and continuous quality improvement. You will collaborate with CMOs and internal teams to ensure GMP compliance and product quality across global vaccine production.

The role emphasizes oversight of sterile manufacturing, QA systems, and risk management, with travel to US or international sites as needed.

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 with aseptic processing and sterile manufacturing environments.
• Experience overseeing CMOs/CDMOs and managing deviations/CAPAs.
• Willingness to travel to US or international sites.

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.
• Lead or participate in internal and external GMP audits and monitor quality metrics with manufacturing partners.

Skills

Quality Assurance

Aseptic processing

Regulatory knowledge

Communication skills

Education

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

Job description

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing in the US, focusing on aseptic fill-finish operations, regulatory alignment, and continuous quality improvement. You will collaborate with CMOs and internal teams to ensure GMP compliance and product quality across global vaccine production.

The role emphasizes oversight of sterile manufacturing, QA systems, and risk management, with travel to US or international sites as needed.