AstraZeneca

Biopharmaceutical

ClinicalQualityAssociateDirector

A$220–330k ~AI est. Sydney, New South Wales, Australia FULL TIME
The Brief

“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.

Biopharmaceutical
Problems you'll solve

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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