About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Position Summary The Sr. Manager, Sterility Assurance, is a highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site. The Sr. Manager Sterility Assurance is responsible to act as the SME during regulatory inspections. Duties/Responsibilities To support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems. Development and management of SOPs, forms, and methods required to support the compliant operation. The Senior Manager, Sterility Assurance plays a critical role in ensuring the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs. Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system. Support equipment, facility, and microbiological method qualifications. Ensure the site and department objectives are met. Manage and develop direct reports. Onboard new materials required to support manufacturing operations. Support manufacturing schedule and needs. Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations, and support career development of direct reports. The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as-needed basis. The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. Occasional travel may be required. Perform other tasks as assigned.