Senior CMO Manager, External Manufacturing

Bavarian Nordic•Durham, NC

1d•Remote

About The Position

The Senior CMO Manager, External Manufacturing owns end-to-end management of contract manufacturing organization (CMO) activities, ensuring reliable, compliant, and timely delivery in collaboration with internal stakeholders and external partners. The role serves as the key interface between Bavarian Nordic and its CMOs, driving alignment, transparency, and performance across manufacturing operations. The position maintains oversight of production activities, monitors performance and KPIs, and ensures operational control. It reviews and approves critical CMO documentation—including deviations, change controls, and manufacturing instructions—in accordance with Bavarian Nordic’s Quality Management System, while ensuring issues are escalated and resolved promptly. The role also manages Work Orders and related financial processes, including invoices; contributes to QMRs, APQRs, and long-range planning; and acts as person-in-plant when required to support collaboration and on-site oversight.

Requirements

At least 7 years of experience in pharmaceutical or biotech manufacturing, including CMO oversight.
Strong 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 and ability to work effectively in a global, cross-functional environment.

Responsibilities

Oversee CMO performance and delivery.
Manage stakeholders and serve as the interface with CMOs.
Establish governance, communication, and ways of working.
Align communication and governance structures between Bavarian Nordic and CMOs.
Support implementation of Bavarian Nordic changes at CMOs.
Facilitate material and information flow to CMOs.
Review and approve CMO documentation, including deviations, change controls, and manufacturing instructions, in accordance with Bavarian Nordic’s QMS.
Ensure timely escalation and resolution of issues.
Maintain operational control, monitor KPIs, and coordinate financial processes, including Work Orders and invoices.
Contribute to QMRs, APQRs, and long-range planning.
Act as person-in-plant when required.
Review LRP protocols, allocation plans, and contract amendments.