AstraZeneca
Biopharmaceutical
ClinicalQualityAssociateDirector
“Clinical Quality Associate Director at AstraZeneca. Skills: Clinical Quality, Cell Therapy, ICH-GCP, Quality Metrics. Provide direction and advice. Support country leadership”
What You'll Achieve.
Surface risks early; Improve investigative performance; Proactive issue management
Industry & Context.
Problem solving
What They're Looking For.
Must Have
Bachelor's degree or equivalent experience, 4+ years operational/quality experience, Knowledge of ICH-GCP, Knowledge of major regulatory frameworks, Hands-on quality events/CAPA management, Experience with Veeva Quality Vault, Develop and use quality metrics, Prepare for audits/inspections, Contribute to inspection responses, Demonstrated stakeholder influence, Demonstrated collaboration across boundaries, Demonstrated problem solving, Demonstrated communication skills, Manage multiple priorities, Operate regionally, Maintain accountability and ownership
Nice to Have
Cell Therapy-relevant procedures knowledge, Experience with Lean Six Sigma, Experience with business process design, Broader Study Management understanding, Cross-functional clinical operations understanding, Support SMM/quality across multiple countries
What You'll Do.
Provide direction and advice
Support country leadership
Plan quality control activities
Develop quality metrics
Track quality metrics
Analyse quality metrics
Provide actionable insights
Support investigations
Approve quality events
Deliver onboarding training
Deliver quality/compliance trainings
Foster engaging quality culture
Consult at country level
Contribute to inspection responses
Develop readiness playbooks
Facilitate country quality risk
Identify compliance risks
Calibrate compliance risks
Track compliance risks
Escalate compliance risks
Define mitigation activities
Support mitigation activities
Participate in CT Quality Network
Embed quality considerations
How You'll Work.
Team & Collaboration
SMM leadership; Process owners; Learning leads; Country leadership; BPQL triangle
Communication Scope
Stakeholder influence; Communication skills
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