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Director of Quality Control Materials
2 months ago
**Job Title:** Director of Quality Control Materials
**Company:** FUJIFILM Diosynth Biotechnologies
**Job Summary:** We are seeking a highly experienced and skilled Director of Quality Control Materials to lead our global quality control materials team. The successful candidate will be responsible for driving the development and implementation of our global QC material strategy, ensuring compliance with regulatory requirements, and overseeing the tech transfer area related to materials in QC.
Key Responsibilities:
- Develop and implement a global QC material strategy that aligns with the company's overall quality objectives
- Ensure compliance with regulatory requirements, including USP, EU GMP, and 21 CFR part 210, 211, 820, 11
- Oversee the tech transfer area related to materials in QC, including agreement with customers and vendors
- Ensure continued improvement and capacity development via the QC materials network
- Enforce established policies, processes, and procedures, and identify areas for enhancement
- Cross-functional collaboration and project team leadership assignments consistent with personal strategic, operational, and technical leadership
Requirements:
- Master's Degree in a relevant field, such as chemistry, biology, or pharmaceutical sciences
- At least 8 years of experience in analytical testing, preferably raw material testing and release, and GMP experience
- 5 years of management experience, with excellent people management and coaching skills
- Project management skills and excellent verbal and written communication skills in English
- Desirable: excellent communication skills in Danish
What We Offer:
- Competitive salary and company bonus scheme
- 35 days of holiday, plus bank holidays
- Salary Sacrifice scheme offering, healthcare, bikes, dental, etc.
- Generous pension scheme
- Free parking and electric charging points
About Us:
FUJIFILM Diosynth Biotechnologies is a dynamic global company that combines technical leadership in cell culture, microbial fermentation, and gene therapies with world-class cGMP manufacturing facilities to advance tomorrow's medicines.
