A start-up affiliate in the biopharmaceutical area is hiring a Head of Quality Europe, QP to build out their European operations in Germany. You will be the primary Quality contact in Europe for my client and liaise with regulatory agencies (FDA, EMA) and regularly conduct site-inspections.
You will be responsible for the release of parental biopharmaceutical products for investigational products (phase I-III) and medicinal products in accordance with regulatory authorisations, EU regulatory requirements, applicable quality agreements, and commercial agreements with my clients marketing partners. They are developing medicines focused on immunology, oncology, and metabolic diseases.
Responsibilities:
- Lead regulatory inspections and responsible for the regular update and revision of MIA Licence
- Assure all products manufactured by my client and third-party contractors fully comply with cGMP regulations
- Assure as EUQP all products of insufficient or dubious safety, quality and/or efficacy are not distrusted
Requirements:
- Certified EU QP
- +10 years of experience releasing biopharmaceutical products
- Thorough knowledge of FDA/EMA regulations
- GMP/GLP Experience
Package:
- Salary ranging 120,000 - 150,000, depending on candidate experience
- Bonus Incentives
Apply:
Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: or phone +44203758831
