AstraZeneca and Alexion
ClinicalQualityAssociateDirector
“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.
Risk management; Root cause analysis
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
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