Support the design and implementation of structured processes to manage external manufacturing partners in API production
Develop and implement a structured approach to managing CMOs in API production
Clarify governance structures, roles and responsibilities, and collaboration models
Contribute to the development and rollout of quality-relevant processes for CMO oversight
Support the implementation of Quality Agreements and related procedures
Establish efficient processes for document exchange, review and approval
Develop and deliver training to ensure sustainable implementation of new processes
Support the initial implementation phase to ensure consistent application

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field
At least 5–7 years of professional experience in the pharmaceutical or life sciences sector, ideally in API/active ingredient manufacturing
Practical experience in CMO management
Solid knowledge of GMP principles and international regulatory requirements (EU GMP, FDA 21 CFR Parts 210/211, ICH guidelines)
Experience with quality management systems, process documentation, or compliance initiatives
Experience with Quality Agreements is an advantage
Strong communication skills and a confident presence when engaging with internal and external stakeholders
Business-fluent German and English (C1 level)

A growing company with ambitious goals, known for expertise, integrity and openness
Exciting projects with reputable clients where you can continuously expand your expertise
Individual development through coaching, training, an internal learning platform, and a strong IT & data network
A balanced work–life arrangement with remote work options, regional or Germany-wide projects, and a 40-hour work week
Security and stability through a permanent employment contract

CMO Management Consultant – API Manufacturing

Key skills