Working with the Processes leads, Process Principals and Compliance Manager, supporting task related to management of AstraZeneca processes including implementation compliance, performance and inspection readiness. 

Accountable for developing relationships across Regulatory Affairs groups and other relevant areas of AZ to execute the delivery of the compliance strategy, priorities, alongside governance and management of the current procedural documents.

Responsibilities:

• Working with the Process  leads and Principals, and  Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global  KPIs related to and regulatory data reporting.
• Reporting of status of Quality events and risks and preparing summaries for stakeholder groups/forum
• Support owners of Quality issues or CAPAs in business to appropriately log in EQMS and manage actions to resolution
• Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
• In collaboration with Head of Reg P&C and Process Leads support communications to relevant business groups to call out actions.  
• follow up of KPI misses and data anomalies
• Provide support and guidance on issue creation, including Root Cause Analysis and CAPAs, follow  up on actions agreed based on compliance data
• Using understanding of PV and Regulatory processes and regulations to provide support to regulatory process and compliance team
• Support training activities for relevant groups in R&D Regulatory Affairs groups in relation to Quality management and compliance monitoring activities
• Coordination of activities in R&D Regulatory Affairs groups for issues managed through Operations Regulatory Deviation framework and Operations Issue Management team (IMTs).
• Management of Licence to operate activities e.g. compliance data collection and complilation
• Performing/oversee the collection and monitoring of compliance data.
• Drive monthly and annual cycles of KPI/Metric data for the Reg KPI dashboard, including Data extracts, review and analysis. Identify opportunities to improve and simplify the methodology in own area of work, provide practical solutions and drive to implementation.
• Support and improve reporting tools and analysis processes and process metric /KPI data. Performing the monitoring, analysis and trending of data in own area of work.
• Contribute to the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
• Develop and improve reporting tools and analysis processes and technology.
• Contibute to analysis and trending. Identify issues and risks and propose options to mitigate them.
• Ensure that appropriate, up-to-date records are maintained for compliance
• Identify issues and risks in own area of work and propose options to mitigate them.
• Ensure that appropriate, up-to-date records are maintained for compliance
•  support activities for GVP, GCP, GRP and GMP audits/inspections
• Support Delivery of improvement project assignments supporting the business,
• Seek personal and professional development opportunities, and share knowledge gained in open forums
• Contribute to communication and change management activities associated with compliance related  initiatives.
• Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities
• Working collaboratively to provide expertise and sharing best practices across all regions

Education, Qualifications, Skills and Experience

Essential:

• A science/pharmacy/nursing degree,
• Experience in working cross-functionally
• Administrative skills including Sharepoint online expertise
• Good attention to detail
• Excellent written and verbal communication skills
• Proven ability to work across cultures
• Strong collaboration skills
• Able to work effectively as a member of a cross-functional or global team
• Understanding of change management process
• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours
• Project Management skills

Desirable:

• Knowledge of Regulatory operating model and organisation
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
• Experience of working with reporting and analysis of data, preferably in support of compliance monitoring activities

Interviews will be done on a rolling bases, therefore do apply as soon as possible

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.