AstraZeneca
Biopharmaceutical
RegionalClinicalQualityAssociateDirector,LateDevelopmentOncology
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“Regional Clinical Quality Associate Director, Late Development Oncology at AstraZeneca. Skills: Clinical Quality, Compliance, Oncology, Late Development. Support execution LDO Quality Framework. Act as first point contact”
What You'll Achieve.
High-quality clinical trial delivery; Meeting high quality standards; Improve investigative performance; Improve proactive issues management; Sustainable issue resolutions
Industry & Context.
Analytical skills; Problem solving; Conflict resolution; Risk-based decision-making
What They're Looking For.
Must Have
Undergraduate degree in life sciences, In-depth knowledge pharmaceutical industry, GxP regulated environment experience, Excellent communication skills, Proven ability to network globally, Critical thinking skills, Influencing skills, Ability to collaborate widely, Ability to network effectively, Ability to interact widely, Ability to interact effectively, Risk-based decision-making skills, Excellent understanding drug development, Excellent understanding GXP activities, Excellent understanding clinical study delivery, Excellent knowledge international regulations, Excellent knowledge international guidelines, Excellent knowledge AZ Procedural Framework, Good analytical skills, Problem solving skills, Negotiation skills, Conflict resolution skills, Ability to multi-task, Ability to set priorities, Ability to manage priorities, Ability to set performance targets, Ability to manage performance targets, Ability to set project initiatives, Ability to manage project initiatives, Ability to collaborate proactively, Ability to deal with ambiguity, Ability to build customer relationships, Ability to build strategic partnerships, Ability to operate across multiple domains, Ability to enable process harmonization, Ability to enable system standardization
Nice to Have
Advanced degree life sciences, Experience with global teams, Experience with remote teams, Ability to work remote collaborators, Expert reputation within business, Expert reputation within industry, Good cultural awareness
What You'll Do.
Support execution LDO Quality Framework
Act as first point contact
Drive strategic focus on quality
Draft regional country quality plan
Manage regional quality control plan
Ensure adherence GCPs
Ensure adherence LDO objectives
Manage country-specific procedures
Maintain country-specific procedures
Manage country-specific guidelines
Maintain country-specific guidelines
Support mitigation training gaps
Provide onboarding training
Coordinate regional exchange forums
Support regional exchange forums
Provide ad hoc training
Highlight procedural changes
Address identified gaps
Share global process updates
Facilitate resolution compliance issues
Promote adoption best practices
Promote sharing best practices
Support investigations
Approve reported quality events
Approve corrective actions
Approve preventive actions
Foster engaging quality culture
Develop compliance improvement recommendations
Implement compliance improvement recommendations
Develop compliance improvement initiatives
Implement compliance improvement initiatives
Develop compliance improvement plans
Implement compliance improvement plans
Offer country-level consultation
Act as key member inspection process
Provide consultation inspection process
Provide green light approval
Identify quality risks
Investigate quality risks
Analyze quality metrics
Interpret quality metrics
Improve investigative performance
Improve proactive issues management
Participate NFM leadership meetings
Support facilitation quality review meetings
Support delivery quality review meetings
Contribute identifying compliance risks
Contribute calibrating compliance risks
Contribute tracking compliance risks
Escalate compliance risks
Define risk mitigation activities
Support risk mitigation activities
Facilitate region quality risk registers
Facilitate country quality risk registers
Manage risk management plan
Collaborate with quality functions
Collaborate with stakeholders
Seek sustainable issue resolutions
Assess need quality site visits
Perform quality site visits
Seek opportunities for improvement
Seek feedback from leadership
Seek feedback from personnel
Foster culture knowledge sharing
Foster culture cross learning
How You'll Work.
Team & Collaboration
Cross-functionally; Globally; NFM leadership team; SMM Oncology leadership; Quality functions; Stakeholders
Communication Scope
Effective networking; Critical thinking; Influencing; Communication
Process & Methodology
Project initiatives management, Performance targets management
Full Job Description
AstraZeneca is one of the world’s leading biopharmaceutical companies, delivering innovative medicines for diseases that pose major challenges to modern healthcare. Our strength comes from the diversity of our people—their experiences, passion, and potential—fueling meaningful progress every day. We act with shared values and the highest ethical standards, combining science, responsibility, and ambition. If you want to make a real impact for patients and grow in an environment that values diversity and collaboration, join us as **Regional Clinical Quality Associate Director, Late Development Oncology.** As a priority, the R-CQADis the first point of contact on quality and compliance matters for the LDO-non footprint (NFM) FSP (functional service provider) associated Oncology Site Management and Monitoring (SMM) functions within AstraZeneca and the FSP providing CRO accordingly. They are responsible for developing, tracking and analyzing quality metrics at region and country level, for all NFM-countries in their assigned region. They provide direction and advice on how to apply GCP principles to NFM/FSP- SMM Oncology personnel so that their work can be conducted while meeting high quality standards. The R-CQAD investigates and consults local specialists on applicable NFM- country regulatory guidance and utilizes expert knowledge onAZ global standards and SOPs to provide compliance advice to associated NFM/FSP staff. The R-CQAD proactively contacts and stays in exchange with the R-DSMM, FSP-CRO DLM and NFM associated country level study teams in order to detect and anticipate quality and compliance risks and actual deviations. **Main Responsibilities:** Main responsibilities of an R-CQAD include: * Support the execution of the LDO Clinical Operations Quality Framework as the first point of contact on quality and compliance matters to the NFM-SMM Oncology Country teams for high-quality clinical trial delivery. * Drive strategic focus on quality for the Oncology portfol
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