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 Lab Services within U.S Product Development
2. Responsible for building up and maintaining a state-of-the-art Quality System for the U.S. Product Development area in FIPCUS
3. Responsible for commissioning, calibration and qualification of the U.S. Product Development Labs, systems, utilities and equipment
4. Responsible for ensuring that the appropriate Standard Operating Procedures (SOP’s) are in place for utilisation of the labs
5. Responsible for ensuring that a maintenance and calibration program is in place for the labs and that preventive and corrective maintenance and calibration is done in due time and documented appropriately
6. Build strong and effective working relationships with Quality Assurance, Regulatory Affairs, Technical Operations and other GPRD areas and possible external partners.
7. Responsible for ensuring that all relevant regulations and guidelines are adopted and followed in the area
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 daily supervision of the staff and area under responsibility
11. Write, review and approve, protocols, reports and SOP’s
· M.Sc., preferably with a Ph.D. in pharmacy, chemical engineering or equivalent qualification.
· Minimum 7 years of experience in the pharmaceutical industry
· 3 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 qualifications and validations of equipment and systems
· Experience with the Product Development Process
· Team player and effective problem-solver
· Excellent communication skills, both verbal and written
Ability to motivate people
Ferring Pharmaceuticals, Inc. - 13 months ago