Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.
This position will assume a leadership role to manage projects in support of the development/implementation of manufacturing processes of new Auto Injectors products at the site. In addition, this position will also manage projects to maintain existing Auto Injector products to be in compliance with regulations and or customer requirements. The position will be responsible to oversee the development and maintenance of project timelines and cost information for the site and to work with the project teams to ensure execution to project plans meets expectations.
The position will be responsible to asses risk, develop mitigation plans and to lead regular team meetings working cross functionally with the sites Manufacturing, Quality Assurance, Quality Control, Validation, Technical and Regulatory departments. Interaction with colleagues outside the site and with customers will also be required. The position will be required to report on a regular basis to the sites leadership team. The new products and processes developed must allow for manufacturing to occur in compliance with cGMP’s, regulatory standards, company policies and site processes.
Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. This manager’s work will be accomplished while sitting, walking and standing. Attendance and participation in various departmental and site leadership team meetings will also be required. This position will require travel between the sites multiple locations (approximately 10 miles apart) and occasional travel outside of St. Louis.