Senior CMO External Manufacturing Lead

Bavarian Nordic Inc.; North Carolina; Remote; USD 150,000 - 195,000; Full time

Job summary

Bavarian Nordic, a global vaccine company, seeks a Senior CMO Manager to own end-to-end management of CMO activities, ensuring compliant and timely delivery. You will interface with CMOs, monitor production KPIs, and handle deviations, change controls, and critical documentation in line with BN QMS.

The role involves financial coordination, planning, and on-site support as needed, with remote flexibility and a focus on cross-functional collaboration across QA, QC, Supply Chain, MSAT, and

Qualifications

• 7+ years' experience in pharmaceutical or biotech manufacturing with CMO oversight.
• Expertise in deviation management, change control, and Quality Management Systems (QMS).
• Solid understanding of regulatory requirements for drug substance and/or drug product manufacturing.
• Broad cross-functional knowledge across QA, QC, Supply Chain, MSAT, and Regulatory Affairs.
• Proven stakeholder management skills in a global, cross-functional environment.

Responsibilities

• CMO performance oversight and delivery
• Stakeholder management and CMO interface
• Governance, communication, and ways of working
• Quality oversight, documentation, and compliance (QMS)
• Operational control, KPIs, and financial coordination
• Align communication and governance structures between BN and CMOs
• Ensure implementation of BN changes at CMOs
• Support and facilitate material and information flow to CMOs
• Handle deviations and change controls in alignment with BN QMS
• Review LRP protocols, allocation plans, and contract amendments

Skills

CMO oversight

Deviation management

Change control

QMS compliance

Regulatory knowledge

Cross-functional collaboration

Job description

Bavarian Nordic, a global vaccine company, seeks a Senior CMO Manager to own end-to-end management of CMO activities, ensuring compliant and timely delivery. You will interface with CMOs, monitor production KPIs, and handle deviations, change controls, and critical documentation in line with BN QMS.

The role involves financial coordination, planning, and on-site support as needed, with remote flexibility and a focus on cross-functional collaboration across QA, QC, Supply Chain, MSAT, and