Job Title:   Senior Manager IT Quality 
Location: TRIL GTC
GCL : E1

AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We’re constantly moving forward as a company – agile and purposeful in our work.

Who we are

We need great people who share our real passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. We bring new kinds of teams together across business areas and geographies, to pursue discoveries beyond inspiring.

Your team at AstraZeneca is made up of a global network of individuals from our business as well as the wider scientific world.

We continuously craft partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

We’re stronger because of our network of teams across the globe. We’re constantly learning and developing through the collaboration and communication between our people and a wide field of experts.

Culture

Working on a strong pipeline means so much more than producing innovative, groundbreaking medicines.

It allows AstraZeneca people to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

We explore innovations and confront challenges that others won't, in order to have a greater impact on patients' lives.

We're proud of our pipeline – It’s not only changing the face of our industry for good, it’s transforming the careers of our people. We’re committed to a culture of continuous learning and people development so everyone at AstraZeneca can grow and thrive.

Values

Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.

Our science lives beyond our labs – our global perspective means we use talent and expertise from all over the world to make our medicines a success.

Our mission is ambitious and it takes the skills of a reciprocal team to really deliver on what science can do.

AZ IT Quality Management – IT Quality Manager

Protecting AZ license to operate through delivery and maintenance of compliant innovation, projects and services.

This function comprises Quality Management professionals that understand AZs business processes and are experts at integrating business appropriate risk management techniques.

This function will also consult and educate business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.

The function is truly global in scale with resources in Asia, EU, North America and South America.

Accountabilities:

You will facilitate the realization of the Quality Management strategy for specific areas in Quality Management.

• Accountable for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet AZ internal and external regulatory requirements
• Act upon risks and issues in order to raise compliance and quality levels within IT and the business
• Supports the development and roll out of training, education and awareness campaigns for quality and compliance.
• Contributes to the continuous improvement of IT Polices, standards and procedures.
• Collaborates with system/business process owner to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks.
• Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements.
• Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
• Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
• Leads / Participates in the Supplier Assessment to ensure that IT Suppliers meet AZ Regulatory requirements.
• Act as a QC point of contact for any potential internal and/or regulatory inspection

You will work with:

IT and Business groups supporting the full lifecycle and value chain.

Essential Requirements:

• Strong communication, influencing and relationship building skills, capable of discussing technical IT terms with a non-technical business audience
• Ability to make pragmatic decisions by analysing highly complex situations, assessing risks and stabilizing strategic and tactical compliance/quality requirements
• Experience of providing regulatory support including validation of laboratory and business applications.
• Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
• BA, BS in Computer or Life Sciences or equivalent, with 3-5 years of experience in the pharmaceutical industry regulatory requirements
• Experience of contributing to implementation of a Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
• Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
• Strong change leadership and team working skills

Desirable Requirements:

• Broad IT management experience including project or service management
• Familiarity with technical concepts in infrastructure or applications
• External qualifications such as ISPE PCC CPIP and ISACA CISM

Apply now to learn more about this exciting opportunity with a world renowned pharmaceutical brand!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by labeling

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. 
 

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.