Quality Systems and Compliance Lead

AstraZeneca•Rockville, MD

About The Position

The Quality Systems and Compliance Lead guides and supports the execution and continuous improvement of site Quality Systems and Compliance activities at an autologous cell therapy manufacturing site with products in clinical development and commercial manufacturing. The role is a key point of contact for deviation and CAPA management, change control governance, Quality Management Review preparation, and Annual Product Quality Reviews. The position leads site self-inspections and coordinates readiness for regulatory inspections, corporate audits, and partner audits, ensuring procedures are followed and audit commitments and responses are managed in a timely manner. It also develops and reports quality data metrics and participates in cross-functional governance forums to support compliance with GxP requirements and regulatory expectations. The role may require work outside standard business hours to support time-sensitive product release activities and patient dosing schedules.

Requirements

At least 7 years of applicable quality experience and a bachelor's degree in science, engineering, or a related technical field.
Experience writing and investigating quality records.
Ability to work in a fast-paced environment across multiple technical functions.
Strong knowledge of cGMPs and ability to interpret regulatory requirements and provide practical compliance guidance to cross-functional teams.
Experience leading or supporting GxP audits or self-inspections and supporting or hosting health authority inspections.
Ability to analyze quality data, identify trends and risks, prepare clear reports, and manage multiple priorities.
Strong facilitation, written communication, and stakeholder-management skills.
Proficiency with electronic quality systems, reporting tools, and standard Microsoft applications.
Ability to make decisions that balance patient safety, compliance, and supply.

Nice To Haves

Master's degree in science, engineering, or a related technical field.
Autologous cell therapy manufacturing or quality experience.
Experience preparing or coordinating Annual Product Quality Reviews.
Lead auditor training or a recognized quality auditing certification.
Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.

Responsibilities

Support 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 outcomes from site Quality System governance meetings, including Deviation Review Board, Change Control Review Board, and Quality Management Review meetings.
Coordinate inputs for Quality Management Review and assist with developing metrics, slides, and presentation materials; connect meeting outcomes to actions, prepare minutes, and track action progress.
Plan, lead, and document site self-inspections as lead auditor, including defining scope, coordinating audits, evaluating objective evidence, preparing reports, and tracking corrective actions through closure.
Guide preparation, review, and timely completion of Annual Product Quality Reviews, coordinating cross-functional inputs.
Support site inspection readiness through walkthroughs, readiness assessments, inspection preparation, front-room and back-room support, and tracking observations, commitments, and responses through closure.
Provide guidance on compliance with global regulations, international standards, and industry best practices for quality management systems, including applicable cell therapy requirements.
Analyze quality-system data and develop 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 in the Electronic Quality System for relevant functional areas; assist with and conduct deviation investigations and root cause analysis.
Liaise with AstraZeneca global stakeholders across multiple time zones to align on best practices and harmonize the Quality Management System.
Work outside standard business hours as needed to support time-sensitive product release activities and patient dosing schedules.
Complete additional assigned duties that support site, quality, compliance, and business objectives, consistent with the scope and level of the position.