Accountable for the performance/delivery of the QASF quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks. Develop and implement, and continuously improve standard procedures and training for team-members related to quality systems. Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Quality Assurance staff and cross-functional partners and escalate to senior management as needed. Lead and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams. Act as a QASF subject matter expert on behalf of the facility during audits and inspections. Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs. Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner. Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing. Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management. Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems. Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making. Champion a culture that embraces psychological and physical safety of employees in the work environment. Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence. Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge. Spend time coaching and mentoring operators and QASF staff while on the manufacturing floor. 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. Ability to research, understand, interpret, and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications. Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Ability to think strategically, meet deadlines, and support work prioritization Ability to negotiate and influence to craft mutually beneficial solutions Ability to motivate and foster a positive team environment Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality Pioneering mindset and ability to create innovative solutions. Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva. Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred. Demonstrated experience with quality management systems. Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP) Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 6+ years of relevant cGMP experience, preferably with 2+ year of QA shop floor experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Project management experience is preferred.