CMO Management Consultant supporting the design and implementation of API production processes in a consulting firm. Involvement in quality management and stakeholder collaborations.
Responsibilities
As a CMO Management Consultant, you support the design and implementation of structured processes to manage external manufacturing partners in the area of API manufacturing
Build and implement a structured approach for managing CMOs in API production
Define governance structures, 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
Requirements
Completed bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering or a comparable field
Minimum 5–7 years of professional experience in the pharmaceutical or life sciences industry, ideally in the area of API/active ingredient manufacturing
Practical experience in CMO management
Solid knowledge of GMP principles as well as international regulatory requirements (EU GMP, FDA 21 CFR Part 210/211, ICH guidelines)
Experience with quality management systems, process documentation or compliance initiatives
Experience working with Quality Agreements is an advantage
Strong communication skills and a confident manner when dealing with internal and external stakeholders
Business-fluent German and English (C1 level)
Benefits
A growing company with ambitious goals that stands for expertise, integrity and openness
Exciting projects with renowned clients where you can continuously expand your expertise
Individual development through coaching, further training, an internal learning platform and a strong IT & Data network
A balanced work–life with home office options, regional or Germany-wide projects and a 40-hour week
Security and stability through a permanent employment contract
At GMS we actively promote equality and diversity. We provide a safe working environment in which all employees have equal opportunities—regardless of age, ethnic origin, sexual orientation, gender, disability or other factors beyond qualification and performance.
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