CMO Management Consultant (API-Production)

GMS is an operational management consulting firm with expertise in data and digital systems. Whether it's digitization, Data & Analytics or Compliance – our consultants are the missing piece in the digital transformation of our clients. We support them on their way to continuous digital development and turn challenges into opportunities. GMS is part of the MoOngy Group, a European conglomerate with over 18 years of experience in IT and engineering expertise.

Your tasks as CMO Management Consultant

As CMO Management Consultant, you will support the conception and implementation of structured processes for controlling external production partners in the area of API-production.

Tasks

• Setup and implementation of a structured approach to controlling CMOs in API-production
• Clearing up governance structures, responsibilities, and collaboration models
• Participation in developing and introducing quality-relevant processes for CMO monitoring
• Support in implementing Quality Agreements and related procedures
• Etablishment of efficient processes for document exchange, review, and approval
• Creation and conduct of training sessions for sustainable implementation of new processes
• Accompaniment of the initial implementation phase to ensure consistent application

Requirements

• 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, preferably in the context of API or active substance production
• Practical experience in CMO management
• Fundamental knowledge of GMP principles and international regulatory requirements (EU-GMP, FDA 21 CFR Part 210/211, ICH guidelines)
• Experience in quality management systems, process documentation or compliance initiatives
• Experience in dealing with Quality Agreements is an advantage
• Communication strength and confident appearance when interacting with internal and external stakeholders
• Fluent German and English skills (C1 level)
• The position is hybrid. Applicants must live in Germany, preferably in the Rhine-Main region.

Benefits

• A growing company with ambitious goals that stands for expertise, integrity and openness
• Fascinating projects with well-known clients where you can continuously expand your expertise
• Individual development through coaching, further education, an internal learning platform and a strong IT & data network
• A balanced Work-Life-Balance with home office options, regional or nationwide projects and a 40-hour workweek
• Safety and stability through an unbound employment contract

GMS actively promotes equality and diversity. We create a safe working environment where all employees have the same opportunities – regardless of age, ethnic origin, sexual orientation, gender, disability or other factors except qualification and performance.

All applications with suitable qualifications are warmly welcome.

If you would like to apply with us? Then we look forward to receiving your CV.

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