Deviations Attend alignment meetings. Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met. Complete investigations for deviations. Ability to perform a review of drafts completed by the technical writers and provide feedback, coaching, and mentoring. Facilitate process and site knowledge to MO organization and coordinate ongoing change efforts. Ability to track and trend deviations (closure time and pattern/re-occurring events). Responsible for opening CAPAs as needed. Ensure on-time closure of CAPAs and Effectiveness Checks for the MO organization. Responsible for on-time closure of Change Controls Actions for the MO organization. Responsible for opening Parent Change Controls and Change Control Actions as needed to revise documents to support new product/process implementation. Facilitate pre-CCRB meetings and attend CCRB. Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Ability to complete CAPA Actions within QMS. Ability to challenge and/or justify CAPA Actions. Ability to identify compliance gaps and work cross functionally with stake holders to make necessary updates to documents. Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation. Ability to challenge and/or justify Change Controls. Ability to lead and participate in continuous improvement initiatives. Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products. Knowledge of cGMP and FDA regulated industry. GMP, Quality, and in-depth risk management knowledge. Basic mathematical skills. Strong technical and compliance writing capability. Proficient in MS Office applications. Background to include an understanding of biology, chemistry, medical or clinical practices. Previous experience leading and closing deviation investigations. Working experience in the CAPA process and ability to identify and verify effectiveness. Advanced working experience of deviation investigations, utilizing root cause analysis tools. Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. Experience supporting health authority inspections. Knowledge of data trending and tracking, including use of statistical analysis software a plus. Demonstrate advanced problem-solving ability/mentality, technical adeptness and logical thinking. Ability to set priorities, manage timelines and effectively react/manage changing priorities. Ability to work with management (global and site) and support corporate and department goals. Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers. Hands on experience preferred with CAR T or biopharmaceutical manufacturing. Ability to train and mentor junior associates to foster and develop their expertise. Ability to hire and recruit candidates. Knowledge of performance management (i.e performance reviews). Prior people management experience preferred. Critical thinking skills necessary to resolve conflicts effectively. Bachelor's degree and 5 years of Manufacturing or Operations experience in a regulated environment. OR Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience in a regulated environment. High School Diploma/GED and 10 years of Manufacturing or Operations experience in a regulated environment. A minimum of 2 years of leadership (people management) experience or mentorship of junior associates is required.