Quality Systems and Compliance Lead

Brief Job Profile Description This role will be responsible to guide and support the execution and continuous improvement of site Quality Systems and Compliance activities. The individual will serve as a key point of contact for deviation and CAPA management, change control governance, Quality Management Review preparation, and Annual Product Quality Reviews for an autologous cell therapy manufacturing site with products in clinical development and commercial manufacturing.  This person will be responsible to execute site self-inspections and coordinate inspection readiness activities for regulatory inspections, corporate audits, partner audits by ensuring the compliant execution of established procedures including (but not limited to) timely management of audit commitments and responses. Quality data analysis metrics development (and report execution), and participation in cross-functional governance forums will be required to ensure compliance with GxP requirements and regulatory expectations.   Accountabilities   • Support the effective execution and continuous improvement of site quality systems in alignment with AstraZeneca Cell Therapy procedures and applicable regulatory requirements.  • Prepare for, facilitate, and communicate the outcomes of the routine site Quality System governance meetings (including, but not limited to, Deviation Review Board, Change Control Review Board, and Quality Management Review meetings).  • Support Quality Management Review preparation by coordinating inputs and assisting with the development of metrics, slides, and presentation materials. Connect cross-functional meeting outcomes to defined actions, generate meeting minutes, and track progress of quality actions.  • Plan, lead, and document site self-inspections as a lead auditor, including defining scope, coordinating audit activities, evaluating objective evidence, preparing reports, and tracking corrective actions through closure.  • Guide the preparation, review, and timely completion of Annual Product Quality Reviews, including coordinating cross-functional inputs.  • Support site inspection readiness initiatives, including facility walkthroughs, readiness assessments, inspection preparation, front-room and back-room support, and tracking observations, commitments, and responses through closure.  • Provide expert guidance on site compliance with global regulations, international standards, and industry best practices for quality management systems, including, but not limited to, ICH Q8, Q9, Q10, and Q12; 21 CFR Parts 11, 210–211, and 600–610; EudraLex Volume 4; EU Annex 1; PIC/S Annex 2A; and applicable FDA and EMA guidance for cell therapy.  • Analyze quality-system data and develop clear reports, dashboards, and insights on metrics, trends, risks, and key performance indicators using applicable digital tools.  • Participate in cross-functional Tier meetings.  • Create and manage deviations, change controls, and CAPA records pertaining to functional areas in the Electronic Quality System. Assist with and conduct deviation investigations and root cause analysis.  • Liaise with AstraZeneca global stakeholders across multiple time zones for alignment on best practices and harmonization within the Quality Management System.  • Flexibility to work outside standard business hours, as needed, to support time-sensitive product release activities and patient dosing schedules.  • Completes additional assigned duties, as needed, to support site, quality, compliance, and business objectives, consistent with the scope and level of the position.  Qualifications and Skills   Essential Skills/Experience:    • 7+ years applicable quality experience with bachelor’s degree in science, engineering, or related technical field.  • Experience writing a