Senior Manager - Quality Management

Job Title: Senior Manager - Quality Management

Career Level - E

Introduction to role

Protecting AstraZeneca's license to operate through the delivery and maintenance of compliant innovation, projects, and services. This function comprises Quality Management professionals who understand AstraZeneca's business processes and are experts at integrating business-appropriate risk management techniques. This function will also consult and educate the 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

• 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 AstraZeneca internal and external regulatory requirements.
• Act upon risks and issues to raise compliance and quality levels within IT and the business.
• Support the development and roll-out of training, education, and awareness campaigns for quality and compliance.
• Contribute to the continuous improvement of IT Policies, standards, and procedures.
• Collaborate with system/business process owners 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 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 Exceptions, CAPA, Deviations, Changes, Incidents, and Problems ensuring timely completion and update of System Lifecycle deliverables.
• Collaborate with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
• Lead/Participate in the Supplier Assessment to ensure that IT Suppliers meet AstraZeneca Regulatory requirements.
• Act as a QC point of contact for any potential internal and/or regulatory inspection.
• Drive accountability for the completeness, accuracy, and currency of Quality-related data through effective monitoring, tracking, and reporting.
• Process authoring, ownership, lead, quality review, and/or approval as appropriate.

Essential Skills/Experience

• BA, BSc in Computer or Life Sciences or equivalent, with 3-5 years of experience in the pharmaceutical industry regulatory 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
• 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 communication, influencing and relationship building skills, capable of discussing technical IT terms with a non-technical business audience
• Strong change leadership and team working skills
• Ability to make pragmatic decisions by analysing complex situations and assessing risks
• Concern for impact, analytically minded and able to prioritise and plan using initiative
• High levels of drive, energy, resilience and a desire for professional excellence
• Ability to hold self and others accountable for actions

Desirable Skills/Experience

• 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
• Understanding of Lean principles, tools and techniques

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. Join us in our unique and ambitious world.

At AstraZeneca, our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms. Join us at this crucial stage of our journey in becoming a digital and data-led enterprise.

Ready to make a difference? Apply today!

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.