Ferring International Pharmascience Center US (FIPCUS)
Ferring International Pharmascience Center US, Inc. (FIPCUS) was formed in 2008 as the U.S. Development affiliate of Ferring Pharmaceuticals Inc. FIPCUS is responsible for U.S. clinical development for both local projects (those intended for U.S. commercialization alone) as well as Global projects. As an organization, it is charged with rapid identification, development, and commercialization of products in the clinical specialty areas of Reproductive Health, Orthopaedics, Gastroenterology, and Urology.
1. Responsible for Product Support for GI products within Global pharmaceutical R&D and Lab Services and within U.S Pharmaceutical Product Development
2. Responsible for building up and maintaining a state-of-the-art Quality System for the U.S. Pharmaceutical Product Development area in FIPCUS
3. Ensure the maintenance of high-quality registration dossiers in collaboration with dossiers owners in Ferring (GRAD and TechOps)
4. Responsible for ensuring that planning, performance and reporting of activities of the department are in accordance with the overall business plan and area objectives.
5. Build strong and effective working relationships with Quality Assurance, Regulatory Affairs, Technical Operations and other GPRD areas and possible external partners.
6. Responsible for ensuring that all relevant regulations and guidelines are adopted and followed in the area
7. Responsible for overall training of staff within the area for GxP, access and proper work approaches in the labs including good documentation practices
8. Responsibility for safety and work environment for the area according to the existing delegation order.
9. Responsible for the appropriate and efficient use of resources and for maintaining and developing appropriate competences within the department to achieve the objectives set for the area.
10. Responsible for development of department staff.
11. Authority to select and hire people in cooperation with HR department and according to current guidelines
12. Responsible for budget and planning, reporting and forecasting for the department.
Member of U.S. Pharmaceutical Product Development management team.
· Minimum of M.Sc., with a Ph.D. in pharmacy, chemical engineering or equivalent qualification.
· Minimum 10 years of experience in the pharmaceutical industry
· 5 years of experience in management of staff.
· Deep understanding of FDA and EU regulatory CMC requirements and GxP requirements
· Experience with developing and maintaining quality systems for Product Development including regulated work (Investigational Medical Product)
· Broad experience in the drug development process
· Experience with Product Support including communication with Regulatory Agencies
· Team player and effective problem-solver
· Excellent communication skills, both verbal and written