AstraZeneca and Alexion

ClinicalQualityAssociateDirector

£115–165k ~AI est. United Kingdom FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Clinical Quality Associate Director at AstraZeneca and Alexion. Skills: Clinical compliance, Process excellence, Risk management, Audit readiness. Advise on procedural frameworks. Advise on ICH-GCP”

What You'll Achieve.

Ensure high-quality study conduct; Ensure high-quality decision-making; Ensure audit and inspection readiness; Strengthen execution; Accelerate outcomes for patients; Enable high-quality clinical operations; Enable efficient clinical operations; Ensure robust corrective actions; Ensure sustainable corrective actions; Drive mitigation actions aligned with strategic priorities; Drive consistent outcomes

Industry & Context.

Problems you'll solve

Risk management; Root cause analysis

Eligibility Requirements

Ability to travel nationally/internationally

What They're Looking For.

Must Have

Bachelor's degree in related discipline, Previous experience in pharmaceutical industry, Knowledge of drug development process, Knowledge of GxP processes, Knowledge of ICH-GCP, Knowledge of relevant country regulations, Medical knowledge, Ability to learn relevant AZ Therapeutic Areas, Clinical Study Management experience, Monitoring experience, Study drug handling experience, Data management experience, Ability to travel nationally/internationally

Nice to Have

Advanced degree in life sciences, Formal auditor/assessor training, Experience leading regulatory inspections, Experience implementing digital quality systems, Experience with analytics-enabled risk management, Experience with automation in clinical operations, Success influencing across countries or regions, Experience contributing to global procedure rollouts, Change management certification, Project management certification, Lean/Six Sigma certification, Therapeutic area breadth, Experience training investigational site personnel

What You'll Do.

Advise on procedural frameworks

Advise on industry standards

Advise on local regulations

Provide regulatory updates

Translate regulatory changes

Support quality control planning

Support quality control execution

Lead audit preparation

Resolve audit findings

Implement corrective actions

Measure corrective actions

Capture learnings from audits

Communicate learnings from audits

Oversee country-level risk management

Identify compliance risks

Drive mitigation actions

Evaluate potential fraud

Manage potential misconduct

Identify training needs

Support investigational site staff

Support global procedure implementation

Provide feedback on procedures

Collect user questions

Lead local procedural document development

Maintain local procedural documents

Train on local procedural documents

Archive local procedural documents

Align local documents with global processes

Align local documents with ICH-GCP

Align local documents with local regulations

Interface with Quality Assurance

Participate in regional network

Contribute to collective goals

Represent organization in expert groups

Provide expert opinions on local regulations

How You'll Work.

Team & Collaboration

Local site management; Local leadership; Regional collaboration; Global collaboration; Quality Assurance; Regional clinical quality leader; Investigational site staff; Subject matter experts; Regional network

Full Job Description

**Job Title: Clinical Quality Associate Director** Location: UK ( Filed based) **Salary: Competitive** **Introduction to role:** Are you ready to raise the quality bar in clinical trials and turn your expertise into real impact for patients? Do you thrive at the intersection of compliance leadership, training, and proactive risk management where your decisions enable faster, safer study delivery? As Clinical Quality Associate Director, you will be the advisor for clinical compliance and process excellence within the local site management and monitoring organization. You will shape how our studies are delivered by elevating standards, sharpening risk based approaches, and ensuring audit and inspection readiness across the portfolio. Working closely with local leadership and collaborating regionally and globally, you will drive a continuous improvement mindset that strengthens execution and accelerates outcomes for patients and healthcare professionals. This role blends strategic influence with hands-on leadership. From guiding teams through regulatory change to steering country level risk management and championing training, you will enable high-quality, efficient clinical operations. Your work will connect directly to our mission bringing life changing medicines to patients with speed and confidence. Accountabilities: * Advise Local Study Teams on procedural frameworks, ICH-GCP, industry standards, and relevant local regulations to ensure high-quality study conduct and decision-making. * Provide accurate, timely updates on local clinical trial regulations and translate changes into actionable guidance for teams. * Support local management in planning and executing Quality Control activities according to the local QC plan, focusing on prevention and continuous improvement. * Lead preparation and follow-up for audits and inspections; serve as the primary local point of contact for auditors and inspectors. * Advise on resolving audit and inspection findings and ensure

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