Senior QA Lead - External Manufacturing (Remote)

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

Job summary

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing partners in aseptic fill-finish operations for vaccines. You will ensure cGMP compliance, manage QA activities with CMOs/CDMOs, and collaborate with cross-functional teams to uphold product quality and patient safety.

The role requires deep experience with sterile manufacturing, FDA/EU GMP knowledge, and the ability to travel to manufacturing sites in the US or abroad as needed.

Qualifications

• 10+ years of Quality Assurance experience in pharmaceutical or biotech manufacturing
• Experience overseeing CMOs/CDMOs is a must
• In-depth understanding of FDA cGMP regulations, EU GMP Annex 1, sterile fill‑finish operations

Responsibilities

• Ensuring CMOs maintain high quality standards conforming to cGMP in collaboration with BN QAA
• Support QA to enable release of highest quality vaccines
• Manage quality-related issues in aseptic operations including vial filling and labelling
• Promote quality culture and drive continuous improvement with manufacturing partners
• Serve as primary QA liaison between client and CMO and coordinate audits and inspections

Skills

GMP knowledge

QA oversight

Vendor management

Regulatory liaison

cGMP

Education

Bachelor's degree in Life Sciences

Tools

GxP systems

Job description

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing partners in aseptic fill-finish operations for vaccines. You will ensure cGMP compliance, manage QA activities with CMOs/CDMOs, and collaborate with cross-functional teams to uphold product quality and patient safety.

The role requires deep experience with sterile manufacturing, FDA/EU GMP knowledge, and the ability to travel to manufacturing sites in the US or abroad as needed.