CMO Management Consultant – API Manufacturing
Global Market Solutions - Germany
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt am Main • Germany
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About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
API manufacturingCMO managementGMP principlesquality management systemsprocess documentationcompliance initiativesQuality Agreementsregulatory requirementsICH guidelinesFDA 21 CFR Part 210/211
Soft Skills
strong communication skillsconfident mannerstakeholder managementtraining developmentcollaborationprocess implementationorganizational skillsproblem-solvingleadershipinterpersonal skills