Job Description

Job Title: Senior Quality Associate – Accredited Diagnostic Development Laboratory

Location: Cambridge, UK

Introduction to role

Precision Diagnostics Development (PDD) within AstraZeneca focuses on matching medicines to those patients most likely to benefit and delivering companion and complementary diagnostics aligned to drug development to enable personalised healthcare across our clinical portfolio. Are you ready to raise the quality bar for innovative diagnostic assays that help match the right patients to the right medicines faster?

Working alongside a dedicated Quality Manager and partnering closely with laboratory scientists, clinical and translational teams, biomarker specialists, regulatory colleagues, and external collaborators, you will ensure assays are developed, validated, implemented, and delivered under CAP/CLIA, ICH GCP, IVDR and ISO 13485. Do you thrive at the intersection of science and regulation, translating complex requirements into pragmatic systems that elevate performance across a fast-moving pipeline?

Accountabilities

• Quality Management System Ownership: Lead day-to-day management of the Lab QMS within the enterprise electronic content management system, ensuring procedural documents are current, clear, and effective so teams can execute first time, every time.
• Change Control Leadership: Maintain oversight of lab change control, driving robust impact assessments, document updates, and effectiveness checks that safeguard data integrity and continuity of operations.
• Issue Investigation and CAPA: Identify, triage, and investigate quality issues, complaints, and non-conformances using root cause analysis; generate and track corrective and preventive actions in partnership with lab leadership to prevent recurrence and strengthen the system.
• Continuous Improvement and Training: Spot gaps and opportunities, then design targeted training and streamlined processes that make compliance intuitive and measurable for lab staff.
• Operational Partnership and KPI Reporting: Collaborate with Lab Operations to embed QMS ways of working; define, monitor, and report quality KPIs that inform decisions and catalyze action across teams.
• Inspection Readiness and Audit Leadership: Lead preparation for CAP inspections, CLIA audits, internal and sponsor audits, and other assessments; coach teams, run mock inspections, and ensure robust, defendable records and responses.
• Supplier Quality Oversight: Participate in supplier evaluation and maintain supplier files, ensuring external partners meet the standards required for regulated laboratory activities.
• Design Control for Assay Development: Contribute to design control documentation for assay development, including user requirements, design inputs/outputs, risk management and Design History Files—linking scientific innovation to compliant, patient-ready solutions.

Essential Skills/Experience

• Bachelor's degree in science-related field or equivalent experience in a quality role in a clinical lab setting.
• Experience of electronic content management systems for document control and quality management.
• Excellent organisational, analytical and time management skills with a keen attention to detail.
• Strong leadership, communication, and stakeholder management skills, with the ability to work effectively across matrix teams.
• Good working knowledge of CAP/CLIA, ISO 15189, GCP, ISO14385, IVDR, HTA and applicable standards governing laboratory quality systems, patient testing, and report issuance.
• Minimum 2 years of hands-on quality experience in medical device or IVD industry.

Desirable Skills/Experience

• Experience in companion diagnostic and predictive biomarker development and deployment within pharmaceutical, biotechnology, or accredited diagnostic laboratory settings, working in line with ISO 14971 and ISO 20916.
• Familiarity with digital pathology, image analysis, and computational pathology approaches in a regulated environment.

Why AstraZeneca:
Here you will help shape how diagnostics guide cutting-edge therapies, working on programs that go beyond traditional molecules into new modalities and advanced biotechnologies. We bring unexpected combinations of experts into the same room to spark bold thinking, harness rich data, and turn complex science into usable tests that matter for patients with cancer. You will be empowered to move quickly, take smart risks, and learn with supportive colleagues who value kindness alongside ambition. Your quality leadership will translate directly into earlier, more accurate identification of patients for transformative treatments—advancing science while growing your expertise in an environment built for collaboration and real-world impact.

Step into this role to set the quality benchmark for next-generation diagnostics and accelerate meaningful outcomes for patients—your best work starts here!

Date Posted

11-Aug-2026

Closing Date

29-Aug-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.