Lead or oversee root cause analysis for microbiological and environmental events; drive timely CAPA execution and effectiveness verification under risk-based prioritization- Partner with Site Operations, Animal Care, and Facilities to align microbiology and EM controls with operational reality and risk; provide Quality input on facility, process, and equipment changes- Establish operational metrics and dashboards for the QA / QC microbiology function; report performance, risks, and trends to senior Quality leadership on a recurring cadence- Drive supplier qualification activities for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audit programs as needed- Support strategic initiatives related to the DPF Quality Management System (QMS), inspection readiness, right-first-time execution, and continuous improvement- Act as QA representative in product development meetings, technology transfer, and scale-up activities- Perform internal and vendor audits; track corrective actions and manage audit files; summarize data for annual product reports- Conduct QA oversight activities, including deviation/failure investigations, change control documentation, complaints, SOPs, and product quality reviews- Lead risk assessments and Corrective and Preventive Action (CAPA) programs to proactively address quality issues and prevent recurrence- Lead controlled document collaboration, review, and approval within the electronic document management system- Establish and track key quality indicators (KPIs); present trends and risk analysis to senior leadership- Provide real-time review of clinical case data, which may require procedure and data review outside of normal business hours- Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of projects- Develop and provide guidance on new initiatives and quality improvements; assess internal processes for efficiency- Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion. Manage Quality Assurance/Quality Control programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products- Provide operational leadership for the on-site QA / QC microbiology function at the DPF, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness- Govern the environmental monitoring program for barrier and non-barrier areas of the DPF, including program design review, qualification, periodic trending, signal detection, and continuous improvement- Serve as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise.