ABOUT ASTRAZENECA

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

SITE DESCRIPTION

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you.

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, lunch card, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), Multisport, anniversary awards, additional time off, pension plan, business travel insurance, recognition programme, flexible working hours.

At AstraZeneca, every one of our employees makes a difference to patient lives every day.

Job overview

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

Supporting Regulatory Compliance Principal with 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:

• Using your understanding of  Regulatory Affairs, compliance and KPI management to support regulatory teams.
• Working with the Process  leads and Principals, and Regulatory experts, develop, establish, monitor, report and assess global  KPIs related to and regulatory data reporting.
• Support monthly and annual cycles of KPI/Metric data for the Reg KPI dashboard, including collection and monitoring of compliance data,  Data extracts, review and analysis.
• based on compliance data and trending, identify areas needing improvement, risks and issues, then following consultation with the  stakeholders and information owners monitor and follow up  on agreed actions
• Ensure that appropriate, up-to-date records are maintained for compliance
• 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 the quality management system and manage actions to resolution
• Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
• Support training activities for relevant groups in R&D Regulatory Affairs groups in relation to Quality management and compliance monitoring activities
• support activities for GVP, GCP, GRP and GMP audits/inspections
• Support Delivery of improvement project assignments supporting the business,

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

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
• Project Management skills

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

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.