Our client, pharmaceutical company specialising in development of biological therapies is now searching for a Senior Quality Systems manager to lead activities related to effective functioning of quality systems and operations processes.
Lead a team of Quality professionals responsible for Biological GMP Quality compliance.
Ensure effective Quality oversight over biologics development and clinical manufacturing.
Drive and monitor the implementation of a commercial biological quality system in Switzerland and support the setup of commercial facility.
Maintain and improve the company Quality Management System (QMS) in compliance to EMA and FDA requirements.
Pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements.
Manage, mentor and develop direct reports within Quality group
Plan and prepare quality resourcing and budgets.
Assist the Qualified Person for maintaining and improving batch release process and support for the facility and its utilities
Master of Science degree in Pharmaceutical sciences, biochemistry or related discipline or equivalent, with experience in GMP area
Solid understanding of quality management systems and continues process improvement principles.
Highly organized with strong verbal and written communication skills
Fluent English is required, French is highly desirable.
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.