Senior Validation Manager - really make a difference
Join one of the oldest Pharmaceutical companies in the world and help with a direct impact in the lives of people suffering from rare diseases. Apart from the moral satisfaction and the prestige, you will also benefit from modern employment conditions and a good remuneration package.
In this capacity, you will report to the Director Quality Assurance Processes & Facilities within the Quality Management Department, develop and implement validation concepts, and direct the execution of validation projects.
You develop and implement cGMP-compliant systems for process and cleaning validation and ensure compliance with international rules for monitoring extractables / leachables and elemental impurities;
conduct the effective and efficient implementation of validation projects, including the compliant and timely processing of related deviations, investigations and changes;
Ensure the competent and timely creation, review and approval of validation documents (SOPs, site validation masterplan, validation plans, protocols and reports, risk analyzes, etc.) in German and English;
Represent validation concepts and activities at inspections;
Lead the Validation team (approximately 20 employees) and ensure operational resource planning and control;
Develop technical and personal long-term strategies and implement them.
Qualifications & Work Experience:
We wish for a winning and innovative person
University degree as a natural scientist (biology, chemistry) or pharmacist;
Broad experience and in-depth technical understanding in the disciplines of validation;
Sound knowledge of relevant regulatory requirements and international industry standards;
At least 5 years of similar experience in the pharmaceutical industry, ideally in the field of biologics;
A high degree of quality awareness and a flair for process engineering and biochemical relationships;
Analytical thinking and the ability to quickly grasp complex relationships and explain them in an easily understandable, logically structured way;
Assertiveness, communication skills and the ability to approach people of all levels of the hierarchy;
Very good knowledge of German and English (written and oral).