Head of Quality Assurance Drug Substance

2 weeks ago


Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time

FUJIFILM Diosynth Biotechnologies is an industry-leading biologics contract development and manufacturing organization (CDMO) with a global presence in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, and College Station, Texas, USA.

We strive to be the employer of choice, offering a competitive compensation and benefit package that fosters a collaborative, innovative, and rewarding environment where diverse perspectives and people come together united by a common purpose and shared values.

The Head of Quality Assurance Drug Substance will play a pivotal role in advancing the future of medicine through quality assurance excellence. As a key member of our team, you will lead a dedicated group of four highly professional managers with extensive experience in drug substance manufacturing, primarily focused on monoclonal antibodies (mAbs).

As the Head of Quality Assurance Drug Substance, your leadership will ensure the highest standards of quality and compliance, driving continuous improvement and fostering collaboration across all functions. You will oversee all QA processes, ensuring compliance with global regulatory standards and develop and implement QA strategies and policies to enhance operational efficiency.

You will also work closely with cross-functional teams to support seamless manufacturing processes, leveraging your strong leadership and team management capabilities to drive success throughout the entire lifecycle of our customers' products.

To succeed in this role, you must have a Master's degree in Pharmacy or similar qualifications to meet the requirements of a Qualified Person, along with over 10 years of experience in biopharmaceutical production with significant QA experience and at least 10 years in a leadership role.

Technical skills include expertise in QA principles, GMP regulations, and validation of production equipment and processes, as well as excellent communication skills and fluency in English. If you are a proactive and dynamic individual with high integrity and commitment to quality, we encourage you to apply for this exciting opportunity.

Please note that FUJIFILM Diosynth Biotechnologies is an equal opportunities employer and welcomes applications from all qualified candidates.

Salary: approximately $120,000 - $150,000 per year, depending on experience and qualifications.



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