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 and investigating quality records. 

• Proven track record 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, as well as supporting/hosting health authority inspections. 

• Demonstrated 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. 

• Demonstrated ability to make decisions that balance patient safety, compliance and supply. 

Desirable Skills/Experience:

• Master’s degree in science, engineering or 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. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.