Axial Quality & Compliance Lead

Axial Quality & Compliance Lead

Location: Lisbon

Global S/4HANA 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.

Role description

As the Axial Quality & Compliance Lead you will be responsible for ensuring that the programme execution and solution aligns with AstraZeneca quality management standards and procedures for this major business transformation. You will have a steadfast passion for quality excellence and a strong customer focus. Working with the core team and local organisations, you will be accountable for assuring that the processes and systems are compliant at the global level (global processes) and at the local level (localizations). This includes engaging with senior team members within the business, IT and Quality functions to ensure that quality and compliance is embedded into the culture, design and methodology of the programme, balancing quality and compliance requirements with the need for agility and flexibility with conformance to standards.

Key Focus areas will be:

• Understanding the quality and compliance risks and requirements for Global business processes and deployments within the scope of the S4/HANA implementation

• Defining and implementing quality and compliance verification activities for the Global programme and each deployment in line with the Axial Master Quality Plan

• Deliver quality and compliance mentorship, templates and training for Axial programme team

• Coordinating investigate reviews in key areas of programme compliance or quality

• Define GxP related workflow, approval and documentation procedures

• Liaison with internal and external assurance partners

• Preparing compliance reports for senior team members

• Encouraging a culture of quality and compliance risk management across the programme teams

Candidate Focus & Challenge

• Anticipating early on that the quality and compliance requirements and pre-requisites are embedded into the overall programme management methodologies

• Developing and implementing a quality management approach and assuring the compliance of the processes and systems with GxP and IT standards

• Assuring that programme governance and processes support quality and compliance standards

• Understanding the range of the business and IT requirements and change impacts associated with fit to standard and global process harmonisations

• Having a positive relationship with the senior team members within the business and IT is important to success in this role

• Collaborating closely with the programme teams and local organizations to ensure the compliance is assured for both the global design and localizations

The Role

• Responsible for the review and validation of the quality and compliance standards across the programme in accordance with AstraZeneca requirements

• Providing assurance on GxP, SOx and other relevant quality compliance for the processes implemented within the solution both for the core design and localizations/deployments

• Understands the big picture and identifies key compliance results along the way

• Enagage with and provide mentorship to the project teams to deliver the quality and compliance standards in order to move through the various stages and decision points

• Develop and supervise quality related important metrics, communicate assurance findings and raise quality, and compliance related risks and issues for resolution

• Lead team members across Business, IT and vendor partners

Interactions:

• Lead the interactions with the local organization

• Understand the expectations from the local team members, business and IT

• Liaise with the local quality organization in each deployment site

• Lead the interactions with the broader programme team

• Working closely with the programme team to support the broader programme schedule and objectives

Candidate Knowledge, Skills & Experience

• Deep knowledge and experience of GxP, SOx and CSV

• Degree or equivalent experience and significant experience in life sciences/pharmaceuticals industry

• Proven experience in sophisticated projects and programmes

• Experience of Operations either on business or IT side, ideally in Manufacturing, Quality Management, and Supply Chain Management

In addition, candidates will be encouraged to demonstrate:

• Excellent communication skills and facilitation skills

• Proficient English

• Experience in global cross functional and multi-cultural companies

• Proven track record in navigating sophisticated partner groups

• A collaborative style and ability to operate successfully in a matrix environment

Why AstraZeneca?

At Astrazeneca we’re dedicated to being a phenomenal Place to Work. Where you are empowered to push the boundaries of science and unleash your ambitious 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.

Are you ready to make a difference? Apply today!