Enterprise Process Expert - Clinical Quality - 24 Month Secondment / FTC

Enterprise Process Expert - Clinical Quality - 24 Month Secondment / FTC

Macclesfield

Axial Programme  

We are one purpose-led global organisation. The enablers and innovators, ensuring that we can fulfil our mission to push the boundaries of science and discover and develop life-changing medicines. We take pride in working close to the cause, opening the locks to save lives, ultimately making a massive difference to the outside world. 

AstraZeneca (AZ) is in a period of strong growth and our employees have a united purpose to make a difference to patients around the world who need both our medicines and the ongoing developments from our science. In this journey AZ must continue to work across borders and with partners and new colleagues in a fast and seamless way. The ambition, size and complexity of the organisation, coupled with the opportunities afforded by new technology, has led the Board to approve a large scale transformation of the IT landscape by the replacement of current ERP (Enterprise Resource Planning) systems with one global solution. 

Our current technology is used by more than 20,000 employees daily, is foundational to all AZ entities and is central to most core business processes. This programme provides the opportunity for real transformation and to shape the way of working globally for many years to come. This programme requires the best. Whether it be the technical skills, business understanding or change leadership, we want to ensure we have the strongest team deployed throughout. The programme seeks to deliver a world class change programme that leaves all employees with a fuller understanding of their role in the end-to-end nature of our global company. This programme will provide AZ with a competitive edge, to the benefits of its employees and patients. 

We now have an opportunity for an Enterprise Process Expert –  Clinical Quality to join the programme on a 24-month secondment/FTC. In this role you will work within the Production to Dispatch Door process area and support the end-to-end business processes related to other Quality functions. 

As an Enterprise Process Expert, you will be responsible for Supporting the Development of Future State Clinical Quality Processes.  The span of operation will likely cover multiple geographies and cultures. 

You will provide support and expertise ensuring that the Future State Processes exploit standard SAP S/4 HANA Capability.  Whilst working collaboratively with the Programme Deployment Team to ensure that the defined processes are delivered in a way that protects Supply to Patients and optimises overall benefit to AstraZeneca. 

You will be considered a Leader within a cross functional team, supporting the development, build and deployment of the Axial global design. Working within the Production to Dispatch Door team, and collaborating extensively with the Clinical Supply Team, this individual will help identify the business change impacts and support strategies to manage the consequences.  Working for the Clinical Quality Process Lead this individual must be a solid teammate and able to see the ‘bigger picture' while also have the capability to drill into detail in own area of expertise. 

What you’ll do 

• Support S/4 HANA Programme activities for Clinical Quality across the business and within the Enterprise Process Area of Production to Dispatch Door 
• Support the development of the S/4 standard process for Clinical Quality across various E2E processes, creating and sustaining key artefacts required for a successful transition 
• Provide relevant expert knowledge in the E2E process and/or SAP S/4 product capability focusing on simplification of existing Clinical Quality responsibilities 
• Work with larger team to create, govern and implement the E2E global standard Clinical Quality processes across the business. 
• Use SAP Best Practices to create the standard global design 
• Ensure that all process development delivers to AstraZeneca and regulatory standards, eg GMP, GDP, GCP, SHE, GxP, SOX, accounting GAAP etc 
• Support establishment of baseline KPIs and measures that can be used to gauge process improvements in Clinical Quality. Support “fit to template” workshops and validate the global design and identify where exceptions lead to local business outcome requirements 
• Link with the data team to define the data requirements for the process, analytics and reporting 
• Develop and support the standardisation and simplification opportunities across the process landscape including Quality Master Data, Quality Release, Quality Control strategy, etc 
• Establish influential and highly collaborative relationships with key regional stakeholders. Create and sustain key assets required to deploy a successful transition to any subsequent generation SAP ERP including the end-to-end process flows, roles, controls and identification of the key information model elements. 

Essential Skills & Experience:

• Bachelor’s degree in relevant field (or equivalent experience)
• Significant experience in Quality (Development and/or Commercial) and Operations (Clinical Manufacture and Supply and / Or Commercial Operations) 
• Improvement within a pharmaceutical or clinical background 
• GMP and GDP knowledge 

• Detailed knowledge and operational experience in SAP QM. 
• Thorough knowledge of Business Improvement processes and local regulations 
• Detailed Understanding of Quality Master Data requirements 
• Demonstrated ability to influence stakeholders including Leadership Teams and/or Site/Functional Leads 
• Ability to successfully deliver IT and/or Business Change across Business Functions 
• Strong Communication and Relationship Building skills with an ability to Influence others to achieve Objectives 
• Ability to interpret and communicate Technical information into Business language 
• Demonstrated ability to successfully deliver IT and/or Business Change across Multiple Locations and/or Business Functions 

Desirable for the role: 

• Advanced degree in a scientific field (or equivalent experience)
• Experience across various Quality areas with ability to see big picture  
• Previous experience with project change management in Quality  
• Extensive knowledge of the latest technical and regulatory expectations including GxP 
• Experience of SAP Intelligent Clinical Supply Management, and Sap Batch Release Hub 
• Experience within a Business Process Management Role 
• Experience of working within a complex IT and/or Change Programme Experience  

Why AstraZeneca? 

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

So, what’s next? 

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

Apply Today!

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