Senior QA Lead — External Manufacturing (Remote)

Regulatory Jobs; United States; Remote; USD 120,000 - 155,000; Full time

Job summary

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing partners under aseptic GMP conditions. You will ensure compliance, product quality, and operational excellence across sterile fill-finish activities including vial filling and labeling, working with CMOs and BN QAA.

The role requires extensive QA experience in aseptic operations, deep regulatory knowledge (FDA cGMP, EU GMP Annex 1), and strong collaboration with Manufacturing, Regulatory Affairs, and

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.
• Overseeing CMOs/CDMOs and external manufacturing oversight.
• Deep knowledge of FDA cGMP regulations and EU GMP Annex 1.

Responsibilities

• Ensure CMOs maintain high Quality standards per cGMP with BN QAA.
• Support QPs to enable release of high quality vaccines.
• Manage quality issues related to aseptic operations, vial filling, labeling, and secondary packaging.
• Drive continuous improvement and promote strong quality culture.
• Represent QA External Manufacturing in global forums and with stakeholders.

Skills

Quality Assurance

Aseptic processing

CMO oversight

Regulatory knowledge

Stakeholder management

Travel readiness

Education

Bachelor's degree

FDA cGMP/ICH knowledge

Job description

Bavarian Nordic is seeking a Senior QA Specialist to oversee external manufacturing partners under aseptic GMP conditions. You will ensure compliance, product quality, and operational excellence across sterile fill-finish activities including vial filling and labeling, working with CMOs and BN QAA.

The role requires extensive QA experience in aseptic operations, deep regulatory knowledge (FDA cGMP, EU GMP Annex 1), and strong collaboration with Manufacturing, Regulatory Affairs, and