Sr. Manager Validation - Global Opportunities
My client is one of the most successful international players in their industry and is now looking for someone to join them and lead their Validation Department. Having an international reach means that you will have the opportunity to transfer to other sites. Which might be an interesting benefit, next to the reputation that comes with working for them, the challenge of the role (lots of technological updating going on so the role will be very broad in terms of responsibilities) and the great atmosphere generated by an non-hierarchical environment.
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).