QA Manager

The ideal candidate for this position will have QA signing authority and responsibility for representing QA on a wide spectrum of projects that require QA oversite and input. This individual will be responsible for day-to-day functions and will also serve a great deal of time in a project capacity. Although not directly responsible as project manager of each associated project, this person must possess strong leadership skills and the ability to be the primary QA resource for those projects. This position will not have any direct supervision of employees, although resources may be allocated for management and direction in order to support projects. As this person will have multiple competing priorities, ideal candidates must not only have strong leadership skills but must also possess an attention to detail and be an excellent communicator. There is also a need to be able to transfer Phase 3 clinical knowledge to support on-going projects and provide key QA support. This individual will report directly to the Director, Quality Assurance. Will interface with day-to-day operations of many departments, including QA and Project Management. Travel may be required periodically, however, the position will be based in Lansing, Michigan.
REQUIREMENTS
10+ years of direct QA experience in a GMP biopharmaceutical environment, including validation, and working within an electronic document management system.

Walking and climbing stairs. Lifting up to 25 lbs. Must possess exceptional interpersonal skills in addition to solid verbal and written communication skills. Must possess exemplary leadership skills and knowledge of project management tools. Must be a self-starter and able to manage and excel in a fast paced environment with multiple priorities. Direct knowledge and experience in the transfer of Phase 3 clinical knowledge is required.

BS in a Biological Science or related field.