Description
QMS Vendor ManagerOur global biopharmaceutical client is looking for an experienced Quality Management System Specialist to support them with their 3rd party Vendor Management. The role will look to ensure the Quality systems are appropriately maintained, developed and good relationships are maintained with suppliers.
Duration: 6 months
Role:
- Review, revision and approval of standard operating procedures (SOPs).
- Manage the vendor qualification system.
- Develop internal and external audit schedules for QMS and execute the audits. Provide final audit reports and perform follow-ups to open items discovered during audits.
- Develop GxP training modules in collaboration with appropriate department managers and conduct required training.
- Assess and maintain the document control system in compliance with all applicable regulations.
- Provide quality assistance to other departments as requested.
- Some minimal travel in Germany to vendor audits required.
Requirements:
- Extensive experience in a vendor management role in a biotechnology or pharmaceutical environment.
- Strong knowledge of and experience with a variety of Quality Management Systems.
- Knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals specifically in relation to QMS.
- Experience with regulatory agencies concerning inspections.
- GMP knowledge and demonstrated ability to establish standards in support of the quality system.
- Strong analytical and problem solving skills
- Excellent communication, interpersonal and training skills as well as organizational skills and attention to detail
- Business fluent in German and English.