CMO Manager (Pharmaceutical, Remote)

Job summary

This temporary position involves managing the end-to-end activities of Contract Manufacturing Organizations (CMOs) within the pharmaceutical sector, ensuring compliance and timely delivery through collaboration with internal and external stakeholders.

Qualifications

• Over 5 years of experience in pharmaceutical or biotech manufacturing, particularly with CMO oversight.
• Strong knowledge in deviation management, change control, and Quality Management Systems (QMS).
• Understanding of regulatory requirements for drug substance and product manufacturing.
• Cross-functional expertise in QA, QC, Supply Chain, MSAT, and Regulatory Affairs.
• Proven ability to manage stakeholders in a global, cross-functional environment.

Responsibilities

• Oversee CMO production activities, monitor performance, and track KPIs.
• Review and approve critical CMO documentation, ensuring compliance with QMS.
• Manage Work Orders and financial processes, including invoice handling.
• Contribute to reporting and planning processes such as QMRs and APQRs.
• Act as person-in-plant for on-site oversight and collaboration.

Skills

• Strong communication and governance skills to align BN and CMOs.
• Ability to implement changes at CMOs and facilitate material flow.
• Proficient in handling deviations and change controls in line with QMS.

Education

• Relevant degree in a scientific or engineering discipline is preferred.

Tools

• Familiarity with manufacturing and quality management software and tools.