Senior CMO Manager, External Manufacturing

Bavarian Nordic Inc.; North Carolina; Remoto; USD 150.000 - 195.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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

Conoscenze

CMO oversight

Deviation management

Change control

QMS compliance

Regulatory knowledge

Cross-functional collaboration

Descrizione del lavoro

Protecting our tomorrow Job Title: Senior CMO Manager, External Manufacturing Location: Remote - East Coast Preferred Department: External Manufacturing Reports To: CMO Director, US Salary Range: $150k - $195k

About Bavarian Nordic Bavarian Nordic is a global vaccine company focused on helping to protect lives through innovative vaccines, public health partnership, and expanded access to disease prevention. We work across emerging infectious diseases, travel health, and public health preparedness to help communities, healthcare providers, pharmacies, and health systems improve vaccine awareness, access, and delivery. With a growing commercial portfolio and strong global partnerships, Bavarian Nordic is evolving how vaccines are supported across healthcare ecosystems - combining scientific innovation with customer engagement, education, and public health impact.

Position Overview

In this role, you will take ownership of the end-to-end management of CMO activities, ensuring reliable, compliant, and timely delivery in close collaboration with both internal stakeholders and external partners. Acting as the key interface between Bavarian Nordic and its CMOs, you will drive alignment, transparency, and performance across all manufacturing operations. A key part of the role is maintaining oversight of production activities, including monitoring performance, tracking KPIs, and ensuring operational control. You will review and approve critical CMO documentation such as deviations, change controls, and manufacturing instructions in accordance with BN QMS, while ensuring timely escalation and resolution of issues. In addition, you will manage Work Orders and associated financial processes, including invoice handling. The role also involves contributing to key reporting and planning processes such as QMRs, APQRs, and long-range planning, as well as acting as person-in-plant when required to ensure strong collaboration and on-site oversight.

Key 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

Qualifications

• 7+ years' 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 with the ability to operate effectively in a global, cross-functional environment

Why Join Us

Join a mission-driven global vaccine company at a pivotal stage of growth and evolution. At Bavarian Nordic, you’ll have the opportunity to help shape innovative commercial programs, support public health initiatives, and contribute to how vaccines are accessed across healthcare channels. We foster a collaborative, entrepreneurial culture where cross-functional partnership, creativity, and impact are valued alongside scientific excellence.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com

Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines

Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions everyday. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic!

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information visit www.bavarian-nordic.com